Evidence-Based Practices for the Fetal to Newborn Transition

Judith S. Mercer, CNM, DNSc; Debra A. Erickson-Owens, CNM, MS, ; Barbara Graves, CNM, MN, MPH; Mary Mumford Haley, CNM, MS

Disclosures

J Midwifery Womens Health. 2007;52(3):262-272.

Effect of Maternal Analgesia on Newborn Transition

Most analgesic agents commonly used to alleviate labor pain readily transfer to the fetus via the placenta. Usually, the effects of the analgesic agents are subtle, as most full term infants transition easily from fetus to newborn. However, some specific medications have the potential to disturb normal neonatal transition.^[2]

Although there is a large body of literature on the various effects of analgesic agents, the reports of neonatal outcomes are often incomplete or inconclusive. The ethical and practical implications of assigning women to various pain management modalities make randomized control trials (RCTs) on pharmacologic management of labor pain and its effect on the neonatal transition difficult to conduct.

A comprehensive literature review (English only) using a combination of search terms (maternal analgesia, effects on newborn, newborn transition, labor drugs, newborn, epidural, first 4 hours, and neonatal outcomes) resulted in three Cochrane Reviews,^[3,4,5] nine systematic reviews (includes RCTs and other types of studies),^{[6,7,8,9,10,11,12,13,14]} six RCTs,^{[15,16,17,18,19,20]} a case control study,^[21] a retrospective cohort study,^[22] and three observational studies.^[23,24,25] These studies compared types of parenteral opioids (dosages, route of administration, and co-drugs), epidural versus parenteral opioids, epidural versus combined spinal-epidural analgesia, epidural dosing (traditional vs. light), and parenteral opioids versus epidural analgesia versus no analgesia. Neonatal outcomes in these studies include Apgar scores, umbilical cord pH, respiratory depression, neonatal sepsis evaluation, breastfeeding success, neurobehavioral effects, and admission to a neonatal special care unit.

Most studies report no effect of analgesic agents (parenteral opioids or epidurals with local anesthetics, with or without opioids) on Apgar scores or umbilical cord pH values.^{[6,11,13,14,17,20]} One systematic review^[9] of RCTs and well designed prospective cohort studies found that newborns exposed to parenteral opioids (5 trials, N = 2015 infants) had a higher incidence of 1-minute Apgar score < 7 compared to newborns exposed to epidural analgesia. However, at 5 minutes, the Apgar scores did not differ significantly (6 trials, N = 2545).

In a Cochrane review by Anim-Somuah et al.,^[4] newborns exposed to epidural analgesia had a decreased risk of having an umbilical cord pH < 7.2 compared to newborns whose mothers had nonepidural analgesia. However, there was no significant difference between groups in 5-minute Apgar scores. Findings from the PEOPLE study, a multicenter RCT (N = 1862), which examined delayed pushing and prolonged second stage of labor in primigravidas with continuous epidural analgesia, found lower umbilical cord pH (<7.15 venous or <7.10 arterial; RR, 2.45; 95% CI, 1.35-4.43) in the newborns whose mothers delayed the start of pushing as compared to the control group who began pushing at the start of second stage.^[26] Yet, no newborns in the delayed pushing group had any sign of perinatal asphyxia as measured by the Neonatal Morbidity Index. These data suggest that Apgar scores and umbilical cord pH are common gross measures of newborn well-being that may not adequately assess the subtle effects of maternal analgesic agents on the newborn.

Morphine, meperidine (Demerol; Sanofi-Aventis, Bridgewater, NJ), and fentanyl are the opioids that have been studied the most in labor analgesia research. These opioids, as well as newer alternatives, such as nalbuphine (Nubain; Endo Pharmaceuticals, Chadds Ford, PA) and butorphanol (Stadol; Bristol-Meyers Squibb, New York, NY), have been associated with newborn respiratory depression. However, there is insufficient evidence to clarify the relationship between medication dosage and respiratory depression at birth. Opioids are known for their high lipid solubility, which allows rapid transfer of the drug through the placenta and into the fetus. The risk of respiratory depression is highest if birth occurs at the time of peak fetal uptake -- between 1 and 4 hours after administration of drug to the mother.^[27]

Naloxone (Narcan; Endo Pharmaceuticals) is currently used in clinical practice to reverse respiratory depression following administration of opioids. One systematic review reported that naloxone administration to the newborn is more common when parenteral opioids and patient-controlled opioid analgesia is used, compared to epidural analgesia.^[9,18,19] Another review found no differences in naloxone use between types of analgesia.^[6] Many of the studies included were too small to draw conclusions for clinical practice recommendations. Naloxone should not be given routinely at the time of birth.^[8]

Lieberman and O'Donoghue^[11] found that epidural use was associated with a higher incidence of maternal fever and subsequent neonatal sepsis evaluation. However, Capogna^[7] suggested that, while the number of neonates receiving sepsis evaluations varies between institutions, there is no evidence that epidural exposure increases the incidence of neonatal sepsis.

There has been a longstanding concern about the negative impact of labor analgesic agents on breastfeeding success. Analgesic effects are known to include suckling inhibition, delay in the establishment of breastfeeding, decreased neonatal alertness, and diminished neurobehavioral function.^[6,12] However, most of these effects were noted in observational studies that were published more than 30 years ago.

In a review^[10] of two prospective cohort studies done more recently (N = 2364), there was no correlation between breastfeeding success and use of either parenteral opioids or epidural/spinal analgesia during labor. Capogna^[7] reports that "theoretically," the types and amount of epidural analgesia may affect breastfeeding success, but suggests early maternal infant bonding may have a greater effect on breastfeeding than does the type of maternal analgesic agent used during labor. The results of a small observational study (N = 28) revealed that neonates not exposed to pain medication exhibited an important prebreastfeeding behavior (spontaneously moving towards the breast and massaging the mother's nipple), which is believed to contribute to suckling.^[23] Newborns (n = 12) in the first 120 minutes after birth, exposed to either intravenous (IV) meperidine, epidural with local anesthetic, or a combination of both had increased amounts of crying and a delay in developing breastfeeding behaviors.^[23] In a study of 129 infants, Riordan^[24] found that fetal exposure to labor analgesia agents (IV opioids or epidural or IV opioids plus epidural) diminished early suckling but did not effect duration of breastfeeding through 6 weeks.

Radzyminski^[25] observed no difference in breastfeeding behaviors when comparing neonates exposed to ultra-low dose anesthetics via labor epidurals (n = 28) to neonates with no exposure to pain medication (n = 28). Beilin^[16] reported that women (n = 58) who received an epidural with high dose fentanyl (>150 mcg) had more difficulty breastfeeding in the first 24 hours compared to women (n = 59) with either an intermediate dose (1-150 mcg) or no fentanyl (n = 60), although the difference did not reach statistical significance. Yet, at 6 weeks postpartum, a greater number of the women in Beilin's high-dose fentanyl group were no longer breastfeeding. In a retrospective cohort study (N = 99), Volmanen^[22] found that more women who had an epidural in labor described not having enough milk when compared to women without an epidural (15 vs. 6, P = .006) in the first 12 weeks postpartum. Lieberman and O'Donoghue^[11] caution in their systematic review that further study is needed to evaluate breastfeeding success rates with the use of epidural analgesia.

Studies of the effect of maternal analgesic agents on early neonatal neurobehavior showed minimal differences in the neurobehavioral scores of newborns exposed to epidural opioids versus newborns exposed to parenteral opioids.^[11] Even results comparing epidural-exposed newborns to newborns with little or no medication exposure did not show a clear difference between groups. Beilin found lower neurobehavioral scores in newborns exposed to high versus low (or none) dose fentanyl (>150 mcg) epidurals.^[16] Intravenous fentanyl just before spinal anesthesia for elective cesarean birth had no impact on neurobehavioral scores.^[15]

No differences were found in neonatal intensive care unit (NICU) admissions of infants exposed to epidural versus nonepidural or no analgesia in labor^[4] or in comparing epidural and combined spinal-epidural analgesia.^[3] Exposure to maternal analgesia does not appear to increase an infant's risk for admission to the NICU.

In summary, the current evidence on the safety of maternal analgesia (parenteral opioids or epidural or combined epidural/spinal) and the effects on the neonate are limited, and at times confusing, making it difficult to draw conclusions for clinical practice. Newborns not exposed to any labor analgesic agents appear to exhibit important prebreastfeeding behaviors necessary for successful suckling sooner than analgesia-exposed newborns, but the effects of labor analgesic agents on early suckling and breastfeeding duration is unclear. The long-term impact of neurobehavioral effects from maternal analgesia is uncertain. Future studies must look beyond gross measures, such as Apgar scores and umbilical cord pH, and focus on long-term neonatal outcomes, such as attachment, breastfeeding duration, and neurobehavioral effects.

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Abstract and Introduction
Effect of Maternal Analgesia on Newborn Transition
The Timing of Umbilical Cord Clamping
Room Air Versus Oxygen for Neonatal Resuscitation
Conclusion
References

Randomized, Controlled Trials on Cord Clamping in Full-Term Infants
Authors, Year, Location	Study Population	Cord Management Placement of Infant	Significant Results	Comments
Chaparro et al. (2006)^[32]; Mexico	Women 37-42 wks; singleton pregnancy, vaginal birth, normal pregnancies, plan to breastfeed for 6 mo, no smokers; no IUGR or major anomalies (excluded after birth); 358 infants randomized	EC: CC at 10 s (mean = 16.5 s); DC: CC at 2 minutes (mean = 94 s); Level: held at the level of the uterus	POV: At 6 mo, DC infants had higher MCV (81 vs. 79.5 fL; P = .001), ferritin (51 vs. 34 mL; P = .0002), and total body iron (48 vs. 44 \0x03BCg/dL, P = .0003) than EC infants. Diff HCT in NB period: 62% vs. 60%; P = .003. After birth, HCT > 70%: DC 13% vs. EC 8%; P < .15. Jaundice: DC 17% vs. EC 14%; P ≤ .36	Largest study to date to look at any long-term outcomes. Conservative in that they used only a 2-min delay. No significant differences in HGB or HCT at 6 mo, but iron stores increased by 27-47 mg in infants with DC. No harmful effects noted.
Cernadas et al. (2006)^[33]; Argentina	276 term infants; vaginal and cesarean birth, no complications, normal pregnancies	EC: CC at 15 s (n = 93); IC: CC at 1 min (n = 91); DC: CC 3 min (n = 92)	POV: Venous HCT at 6 hrs: EC 54% vs. IC 57% vs. DC 59%. HCT < 45% highest with EC at 6 and 24 hrs. HCT > 65% was highest in DC at 6 and 24 hrs without clinical symptoms	No harmful effects were seen. At 24-48 hrs, 16.9% of infants with EC had HCT < 45%. No increase in maternal postpartum hemorrhage. Authors recommend DC.
Emhamed, van Rheenen, and Brabin (2004)^[35]; Libya	Women 37-42 wks; singletons; excluded for major congenital anomalies, maternal complications; tight nuchal cord, need for resuscitation; 102 infants > 2500 gms	EC: immediate (n = 45); DC: after cord stopped pulsating (n = 57); oxytocic after CC	DC infants had significantly higher HCT (53% vs. 49%; P = .004) and Hgb 17.1 vs. 18.5 g/dL (P = .0005) at 24 hrs. Three DC infants had polycythemia with no symptoms; two EC infants needed phototherapy	No perinatal complications from DC in this study. Authors recommend DC as a safe, simple intervention to increase red cell mass.
Gupta and Ramji (2002)^[34]; India	Term infants (n = 102) born to anemic mothers (HGB < 10 g/dL); vaginal birth, no resuscitation needed at birth; no major congenital anomalies	EC: immediate (n = 53); LC: when placenta in vagina (n = 49); Infant held 0-10 cm below introitus	At 3 mos of age (n = 58), infants with LC had higher serum ferritin levels (118 vs. 73; P = .001). Odds risk for anemia at 3 mos was 7.7 times higher for the EC group (95% CI, 1.84-34.9)	EC Infants weighed 2707 gms, LC infants 2743 g. Iron stores in neonates born to anemic mothers can be improved by LC (jaundice and polycythemia not addressed)

CC = cord clamping; DC = delayed cord clamping; EC = early cord clamping; HCT = hematocrit; HGB = hemoglobin; IC = intermediate cord clamping; IUGR = intrauterine growth restriction; MCV = mean corpuscular volume; NB = newborn; LC = late cord clamping; POV = primary outcome variable.

Randomized, Controlled Trials on Cord Clamping in Full-Term Infants
Authors, Year, Location	Study Population	Cord Management Placement of Infant	Significant Results	Comments
Chaparro et al. (2006)^[32]; Mexico	Women 37-42 wks; singleton pregnancy, vaginal birth, normal pregnancies, plan to breastfeed for 6 mo, no smokers; no IUGR or major anomalies (excluded after birth); 358 infants randomized	EC: CC at 10 s (mean = 16.5 s); DC: CC at 2 minutes (mean = 94 s); Level: held at the level of the uterus	POV: At 6 mo, DC infants had higher MCV (81 vs. 79.5 fL; P = .001), ferritin (51 vs. 34 mL; P = .0002), and total body iron (48 vs. 44 \0x03BCg/dL, P = .0003) than EC infants. Diff HCT in NB period: 62% vs. 60%; P = .003. After birth, HCT > 70%: DC 13% vs. EC 8%; P < .15. Jaundice: DC 17% vs. EC 14%; P ≤ .36	Largest study to date to look at any long-term outcomes. Conservative in that they used only a 2-min delay. No significant differences in HGB or HCT at 6 mo, but iron stores increased by 27-47 mg in infants with DC. No harmful effects noted.
Cernadas et al. (2006)^[33]; Argentina	276 term infants; vaginal and cesarean birth, no complications, normal pregnancies	EC: CC at 15 s (n = 93); IC: CC at 1 min (n = 91); DC: CC 3 min (n = 92)	POV: Venous HCT at 6 hrs: EC 54% vs. IC 57% vs. DC 59%. HCT < 45% highest with EC at 6 and 24 hrs. HCT > 65% was highest in DC at 6 and 24 hrs without clinical symptoms	No harmful effects were seen. At 24-48 hrs, 16.9% of infants with EC had HCT < 45%. No increase in maternal postpartum hemorrhage. Authors recommend DC.
Emhamed, van Rheenen, and Brabin (2004)^[35]; Libya	Women 37-42 wks; singletons; excluded for major congenital anomalies, maternal complications; tight nuchal cord, need for resuscitation; 102 infants > 2500 gms	EC: immediate (n = 45); DC: after cord stopped pulsating (n = 57); oxytocic after CC	DC infants had significantly higher HCT (53% vs. 49%; P = .004) and Hgb 17.1 vs. 18.5 g/dL (P = .0005) at 24 hrs. Three DC infants had polycythemia with no symptoms; two EC infants needed phototherapy	No perinatal complications from DC in this study. Authors recommend DC as a safe, simple intervention to increase red cell mass.
Gupta and Ramji (2002)^[34]; India	Term infants (n = 102) born to anemic mothers (HGB < 10 g/dL); vaginal birth, no resuscitation needed at birth; no major congenital anomalies	EC: immediate (n = 53); LC: when placenta in vagina (n = 49); Infant held 0-10 cm below introitus	At 3 mos of age (n = 58), infants with LC had higher serum ferritin levels (118 vs. 73; P = .001). Odds risk for anemia at 3 mos was 7.7 times higher for the EC group (95% CI, 1.84-34.9)	EC Infants weighed 2707 gms, LC infants 2743 g. Iron stores in neonates born to anemic mothers can be improved by LC (jaundice and polycythemia not addressed)

Literature Overview on Infant Placement at Birth and Skin-to-Skin Care
Authors, Year, Study Type	Study Population	Style of Thermoregulation	Results	Comments
Carfoot, Williamson, and Dickson (2005)^[43]; RCT	204 term mother-baby pairs randomized to either group	Early SSC compared with RNC	Higher temps 1 hr after birth (P < .02); no difference in # breastfeeding at 4 mos, mothers more satisfied with SSC (90% vs. 50%)	Largest trial to date; supports no harm with SSC; found warmer infants and high maternal satisfaction with SSC
Vaidya, Sharma, and Dhungel (2005)^[44]; RCT	92 lactating mother-baby pairs followed up to 6 mos	Randomized to 15 min of SSC in the first hrs vs. RNC (babies dressed and given to mother)	Significantly more mothers in the SCC group were breastfeeding at 6 mos of age (77% vs. 38%)	Large study from a resource-poor country; well done; cultural differences may play a role
Fransson, Karlsson, and Nilsson (2005)^[45]; physiologic study	27 healthy term babies during first 2 days of life	Determine normal temperature patterns and variations and the influence of external factors	Skin temperature of baby was higher when with the mother, even if not skin-to-skin	Highest temperatures were recorded when baby was in close contact with mother, lowest when baby was in the cot
Anderson et al. (2003)^[1]; Cochrane review	Cochrane review of 806 participants in 17 studies	Early skin-to-skin contact, baby naked and prone on mother's bare chest versus routine hospital care	Increased scores for maternal love/touch/affection, increased maternal attachment behavior	Safety and breastfeeding success; editors recommended improving methodological and statistical integrity
Ferber and Makhoul (2004)^[46]; RCT	47 healthy mother-baby pairs	All infants had SSC for first 5-10 min. The SSC group had SSC from 15 min to 1 hr of life; control group had routine care in the nursery	At 4 hrs, infants in the SSC group slept longer (P = .02) with more quiet sleep time (P = .01) and had better flexion (P = .03) and less extension of limbs (P = .05)	SSC appears to influence state organization and motor coordination

RCT = randomized, controlled trial; RNC = routine newborn care; SSC = skin-to-skin.

Literature Overview on Infant Placement at Birth and Skin-to-Skin Care
Authors, Year, Study Type	Study Population	Style of Thermoregulation	Results	Comments
Carfoot, Williamson, and Dickson (2005)^[43]; RCT	204 term mother-baby pairs randomized to either group	Early SSC compared with RNC	Higher temps 1 hr after birth (P < .02); no difference in # breastfeeding at 4 mos, mothers more satisfied with SSC (90% vs. 50%)	Largest trial to date; supports no harm with SSC; found warmer infants and high maternal satisfaction with SSC
Vaidya, Sharma, and Dhungel (2005)^[44]; RCT	92 lactating mother-baby pairs followed up to 6 mos	Randomized to 15 min of SSC in the first hrs vs. RNC (babies dressed and given to mother)	Significantly more mothers in the SCC group were breastfeeding at 6 mos of age (77% vs. 38%)	Large study from a resource-poor country; well done; cultural differences may play a role
Fransson, Karlsson, and Nilsson (2005)^[45]; physiologic study	27 healthy term babies during first 2 days of life	Determine normal temperature patterns and variations and the influence of external factors	Skin temperature of baby was higher when with the mother, even if not skin-to-skin	Highest temperatures were recorded when baby was in close contact with mother, lowest when baby was in the cot
Anderson et al. (2003)^[1]; Cochrane review	Cochrane review of 806 participants in 17 studies	Early skin-to-skin contact, baby naked and prone on mother's bare chest versus routine hospital care	Increased scores for maternal love/touch/affection, increased maternal attachment behavior	Safety and breastfeeding success; editors recommended improving methodological and statistical integrity
Ferber and Makhoul (2004)^[46]; RCT	47 healthy mother-baby pairs	All infants had SSC for first 5-10 min. The SSC group had SSC from 15 min to 1 hr of life; control group had routine care in the nursery	At 4 hrs, infants in the SSC group slept longer (P = .02) with more quiet sleep time (P = .01) and had better flexion (P = .03) and less extension of limbs (P = .05)	SSC appears to influence state organization and motor coordination

RCT = randomized, controlled trial; RNC = routine newborn care; SSC = skin-to-skin.

Oropharyngeal Suctioning at Birth*
Author, Year, Study Type*	Intervention and Sample Size	Significant Results	Comments
Cordero and Hon (1971)^[53]; non-randomized	Bulb suction (n = 41) vs. catheter suction (n = 46)	The catheter group developed severe arrhythmia (n = 7) and became apneic (n = 5)	First study to show that suctioning disrupted infant transition
Estol et al. (1992)^[51]; prospective, non-random trial (assigned by hour of birth)	Bulb suction (n = 20) vs. no suction (n = 20)	Respiratory resistance and lung compliance were not different at 10, 30, or 120 min	No significant differences between infants with and without suctioning; no advantage to infants from suctioning
Carrasco, Martell, and Estol (1997)^[50]; RCT	Immediate suction with catheter (n = 15) vs. no suctioning (n = 15)	Suctioned group had lower SaO2 between 1-6 min of life (P < .05); time to reach 86%-92% SaO2 shorter in nonsuctioned group	No respiratory distress in either group; no advantage to infants from suctioning
Waltman et al. (2004)^[52]; RCT	Bulb suction on perineum and just after birth (n = 10) vs. no suction (n = 10)	No difference in Apgar scores at 1, 5, or 10 min; higher heart rate [166-173 (n = 10) bpm] in no suction group compared to suction group (150-166 bpm); lower SaO2 from 10-20 min in non-suctioned group (although > 90%)	No benefits to the infants from suctioning demonstrated

Bpm = beats per minute.
*Study populations: All infants were vigorous term infants.

Current Evidence for Practices Related to Management of Infants Born With Meconium-Stained Amniotic Fluid
Treatment	Recommendation	Reference	Study Details
Amnioinfusion	No benefit to infants found for the prevention of MAS	Fraser et al. (2005)^[54]	Multicenter RCT, women (n = 1998) in labor at term with MSAF stratified by presence of variable decelerations and randomly assigned to amnioinfusion or standard care. Amnioinfusion did not reduce risk of MAS, or perinatal death.
Intrapartum suctioning before delivery of shoulders	No benefit to any infants including high risk infants; suctioning of infant before delivery is not indicated	Vain et al. (2004)^[55]	RCT, blinded, infants (n = 1176) suctioned on perineum compared with infants (n = 1225) not suctioned. No difference in Apgar scores, respiratory distress, use of oxygen, need for ventilation, MAS (4% in each group), or death.
Endotracheal intubation and suctioning after birth of vigorous infants	No benefits to any infants; not recommended for vigorous infants	Wiswell et al. (2000)^[56]	RCT, vigorous term infants (n = 2094) with MSAF randomly assigned to intubation and suctioning or to expectant management. Intubation and suctioning did not result in lower incidence of MAS or other respiratory disorders.

MAS = meconium aspiration syndrome; MSAF= meconium-stained amniotic fluid; RCT = randomized, controlled trial.

Current Evidence for Practices Related to Management of Infants Born With Meconium-Stained Amniotic Fluid
Treatment	Recommendation	Reference	Study Details
Amnioinfusion	No benefit to infants found for the prevention of MAS	Fraser et al. (2005)^[54]	Multicenter RCT, women (n = 1998) in labor at term with MSAF stratified by presence of variable decelerations and randomly assigned to amnioinfusion or standard care. Amnioinfusion did not reduce risk of MAS, or perinatal death.
Intrapartum suctioning before delivery of shoulders	No benefit to any infants including high risk infants; suctioning of infant before delivery is not indicated	Vain et al. (2004)^[55]	RCT, blinded, infants (n = 1176) suctioned on perineum compared with infants (n = 1225) not suctioned. No difference in Apgar scores, respiratory distress, use of oxygen, need for ventilation, MAS (4% in each group), or death.
Endotracheal intubation and suctioning after birth of vigorous infants	No benefits to any infants; not recommended for vigorous infants	Wiswell et al. (2000)^[56]	RCT, vigorous term infants (n = 2094) with MSAF randomly assigned to intubation and suctioning or to expectant management. Intubation and suctioning did not result in lower incidence of MAS or other respiratory disorders.

MAS = meconium aspiration syndrome; MSAF= meconium-stained amniotic fluid; RCT = randomized, controlled trial.

Room Air Versus Oxygen for Resuscitation: Randomized, Controlled Trials and Controlled Trials (1995 to Present)
Authors, Year, Type of Study	Study Population	Intervention and Application	Significant Results	Comments
Ramji et al. (2003)^[66]; quasi-randomized by date of birth	Term newborns needing resuscitation	RA (n = 210) vs. 100% 02 (n = 221)	No differences in mortality, heart rate, Apgar scores, time to first breath, HIE. Time to first cry: RA 2 min vs. 3 min in 02group (P = .008). Duration resuscitation: RA 2 min vs. 02 3 min (P = .000076)	No indication that 100% 02 offers benefits over RA. Resuscitation appears faster with RA
Saugstad et al. (2003)^[71]; follow-up	Infants in prior trials who had reached 18-24 mos	Follow-up of ResAir study (591 infants, of whom 410 available for follow-up)	No differences in: weight, length, developmental milestones, language development, hearing, or cerebral palsy between infants resuscitated with RA vs. 02	No long-term advantage to use of 100% 02. Study weakened by low (70%) follow-up rate
Vento et al. (2003)^[69]; blinded, randomized	Term infants needing resuscitation	RA (n = 51) vs. 100% 02 (n = 55)	No statistical difference in Apgar scores. Time to first cry: RA 1.4 min vs. 02 1.97 min (P < .05). Time to regular respirations: RA 5.3 min vs. O2 6.8 min (P < .05)	No advantage to 100% 02 use
Vento et al. (2001)^[68]; blinded, randomized	Asphyxiated term infants and normal controls	RA (n = 19) vs. 100% 02 (n = 21) vs. controls (n = 26)	No statistical difference in Apgar scores. Time to first cry: RA 1.2 min vs. 02 1.7 min (P < .05). Time to regular respirations: RA 4.6 min vs. 7.5 min (P < .05). Higher levels of markers of oxygen free radicals at 28 days in 02 vs. RA groups	Even a brief exposure to 100% 02 may cause prolonged oxidative stress
Saugstad et al. (1998)^[75]; quasi-randomized by date of birth, not blinded	BW >1000 gm, no major anomalies	RA (n = 388) vs. 100% 02 (n = 311)	No significant difference in mortality, HIE, ABG. Apgar 1 min: RA 5; 02 4 min (P = .004); no difference in Apgar 5 min; more infants w/5 min Apgar < 7 in 02 group (P = .03); Time to first breath: RA 1.1 min, 02 1.5 min (P = .004); first cry: RA 1.6 min, 02 2.0 min (P = .006)	25.7% "treatment failures" in RA switched to 02 at 90 sec; comparable to numbers in 02 group (29.8%) who had bradycardia and/or central cyanosis at 90 s

ABG = arterial blood gas; BW = birth weight; HIE = hypoxic ischemic encephalopathy; 02= oxygen; RA = room air.

Room Air Versus Oxygen for Resuscitation: Randomized, Controlled Trials and Controlled Trials (1995 to Present)
Authors, Year, Type of Study	Study Population	Intervention and Application	Significant Results	Comments
Ramji et al. (2003)^[66]; quasi-randomized by date of birth	Term newborns needing resuscitation	RA (n = 210) vs. 100% 02 (n = 221)	No differences in mortality, heart rate, Apgar scores, time to first breath, HIE. Time to first cry: RA 2 min vs. 3 min in 02group (P = .008). Duration resuscitation: RA 2 min vs. 02 3 min (P = .000076)	No indication that 100% 02 offers benefits over RA. Resuscitation appears faster with RA
Saugstad et al. (2003)^[71]; follow-up	Infants in prior trials who had reached 18-24 mos	Follow-up of ResAir study (591 infants, of whom 410 available for follow-up)	No differences in: weight, length, developmental milestones, language development, hearing, or cerebral palsy between infants resuscitated with RA vs. 02	No long-term advantage to use of 100% 02. Study weakened by low (70%) follow-up rate
Vento et al. (2003)^[69]; blinded, randomized	Term infants needing resuscitation	RA (n = 51) vs. 100% 02 (n = 55)	No statistical difference in Apgar scores. Time to first cry: RA 1.4 min vs. 02 1.97 min (P < .05). Time to regular respirations: RA 5.3 min vs. O2 6.8 min (P < .05)	No advantage to 100% 02 use
Vento et al. (2001)^[68]; blinded, randomized	Asphyxiated term infants and normal controls	RA (n = 19) vs. 100% 02 (n = 21) vs. controls (n = 26)	No statistical difference in Apgar scores. Time to first cry: RA 1.2 min vs. 02 1.7 min (P < .05). Time to regular respirations: RA 4.6 min vs. 7.5 min (P < .05). Higher levels of markers of oxygen free radicals at 28 days in 02 vs. RA groups	Even a brief exposure to 100% 02 may cause prolonged oxidative stress
Saugstad et al. (1998)^[75]; quasi-randomized by date of birth, not blinded	BW >1000 gm, no major anomalies	RA (n = 388) vs. 100% 02 (n = 311)	No significant difference in mortality, HIE, ABG. Apgar 1 min: RA 5; 02 4 min (P = .004); no difference in Apgar 5 min; more infants w/5 min Apgar < 7 in 02 group (P = .03); Time to first breath: RA 1.1 min, 02 1.5 min (P = .004); first cry: RA 1.6 min, 02 2.0 min (P = .006)	25.7% "treatment failures" in RA switched to 02 at 90 sec; comparable to numbers in 02 group (29.8%) who had bradycardia and/or central cyanosis at 90 s

ABG = arterial blood gas; BW = birth weight; HIE = hypoxic ischemic encephalopathy; 02= oxygen; RA = room air.

Room Air Versus Oxygen for Resuscitation: Randomized, Controlled Trials and Controlled Trials (1995 to Present)
Authors, Year, Type of Study	Study Population	Intervention and Application	Significant Results	Comments
Ramji et al. (2003)^[66]; quasi-randomized by date of birth	Term newborns needing resuscitation	RA (n = 210) vs. 100% 02 (n = 221)	No differences in mortality, heart rate, Apgar scores, time to first breath, HIE. Time to first cry: RA 2 min vs. 3 min in 02group (P = .008). Duration resuscitation: RA 2 min vs. 02 3 min (P = .000076)	No indication that 100% 02 offers benefits over RA. Resuscitation appears faster with RA
Saugstad et al. (2003)^[71]; follow-up	Infants in prior trials who had reached 18-24 mos	Follow-up of ResAir study (591 infants, of whom 410 available for follow-up)	No differences in: weight, length, developmental milestones, language development, hearing, or cerebral palsy between infants resuscitated with RA vs. 02	No long-term advantage to use of 100% 02. Study weakened by low (70%) follow-up rate
Vento et al. (2003)^[69]; blinded, randomized	Term infants needing resuscitation	RA (n = 51) vs. 100% 02 (n = 55)	No statistical difference in Apgar scores. Time to first cry: RA 1.4 min vs. 02 1.97 min (P < .05). Time to regular respirations: RA 5.3 min vs. O2 6.8 min (P < .05)	No advantage to 100% 02 use
Vento et al. (2001)^[68]; blinded, randomized	Asphyxiated term infants and normal controls	RA (n = 19) vs. 100% 02 (n = 21) vs. controls (n = 26)	No statistical difference in Apgar scores. Time to first cry: RA 1.2 min vs. 02 1.7 min (P < .05). Time to regular respirations: RA 4.6 min vs. 7.5 min (P < .05). Higher levels of markers of oxygen free radicals at 28 days in 02 vs. RA groups	Even a brief exposure to 100% 02 may cause prolonged oxidative stress
Saugstad et al. (1998)^[75]; quasi-randomized by date of birth, not blinded	BW >1000 gm, no major anomalies	RA (n = 388) vs. 100% 02 (n = 311)	No significant difference in mortality, HIE, ABG. Apgar 1 min: RA 5; 02 4 min (P = .004); no difference in Apgar 5 min; more infants w/5 min Apgar < 7 in 02 group (P = .03); Time to first breath: RA 1.1 min, 02 1.5 min (P = .004); first cry: RA 1.6 min, 02 2.0 min (P = .006)	25.7% "treatment failures" in RA switched to 02 at 90 sec; comparable to numbers in 02 group (29.8%) who had bradycardia and/or central cyanosis at 90 s

ABG = arterial blood gas; BW = birth weight; HIE = hypoxic ischemic encephalopathy; 02= oxygen; RA = room air.

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