Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial

Kelleher, John; Bhat, Ramesh M; Salas, Ariel A.; Addis, Dylan R.; Liu, Christopher; Mallick, Himel; Tripathi, Arvind; Pruitt, Elizabeth; Roane, Claire; McNair, Tara; Owen, John; Ambalavanan, Namasivayam; Carlo, Waldemar A.

doi:10.1016/s0140-6736(13)60775-8

Cited by 55 publications

(35 citation statements)

References 13 publications

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“…Kelleher reported 18% of the wipe group (no suction) and 12% of the bulb suction group required admission in their study, with no statistically significant difference. 13 In present study, seven babies in the wipes group had mild retraction at birth and the distress resolved within 1hour, after observation in the neonatal ward. One neonate in the suction group had <95% saturation at 15 minutes, improved after supplemental oxygen, was observed and monitored for 1 hour.…”

Section: Other Outcomessupporting

confidence: 49%

“…8,11,12 In another trial, the mean respiratory rate in the first 24 hrs was used as the primary outcome. 13 The Pulseoximeter used in 2005 by Gungor and associates was system III, infant monitor, Air shields, USA) for monitoring and measurements were documented minutes by minutes. 11,12 But in our study, we used Masimo radical -7, newer generation Pulseoximeter for recording pulse rate and Saturation and the data was transferred to a computer for analysis.…”

Section: Discussionmentioning

confidence: 99%

“…In Contrast, in Kelleher study, 10% of the wipe group and 7% in the suction group required advanced resuscitation. 13 This is probably because of the broad inclusion criteria in their study. Also, our study includes only neonates cried at birth and hence those neonates depressed or asphyxiated at birth requiring resuscitation was excluded.…”

Section: Other Outcomesmentioning

confidence: 99%

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A Randomised controlled equivalency trial on wiping with a cloth (no suction) versus routine suctioning of oronasopharynx at birth, in term neonates born elective Lscs with clear liquor

Ashokraja

Balasankar

Mathiarasan

2017

Int J Contemp Pediatr

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Background: Efficacy of wiping with a cloth compared to suction in routine care is not known. In term elective Lscs with clear liquor, we hypothesise that it has equivalent efficacy with suction.Methods: Randomized controlled equivalency trial with parallel group design. Inclusion criteria was term neonates born elective Lscs, with clear liquor and cried at birth at Government Rajaji Hospital, Madurai. Major congenital anomalies, Depressed or asphyxiated at birth, Meconium staining, Preterm were excluded. The Primary outcome is the time to reach a saturation of 92%. After randomisation, one group received gentle electrical suction and the other wiping of face, mouth and nose using a sterile cloth. The Pulseoximeter readings in the first fifteen minutes of life were transferred to a computer. Other clinical data collected using a Proforma.Results: Among 270 elective Lscs babies, 112 randomized, 58 received suction and 54 wiping. Excluding four babies, 56 Neonates in the suction group and 52 in the no suction group were analysed. The baseline data was similar except for maternal age. The primary outcome, median time to reach 92% saturation is significantly lesser (7 minutes (m)& 6 seconds(s)), [IQR 4m41s, 9m17s] in the no suction group, than the suction group (8 m18 s) [IQR 6m44s, 10m1s] (P value 0.009 ).Conclusions: In term elective LSCS babies with clear liquor and cried at birth, wiping with a sterile cloth has equivalent efficacy compared to suction for routine care.

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Section: Other Outcomessupporting

confidence: 49%

Section: Discussionmentioning

confidence: 99%

Section: Other Outcomesmentioning

confidence: 99%

See 1 more Smart Citation

A Randomised controlled equivalency trial on wiping with a cloth (no suction) versus routine suctioning of oronasopharynx at birth, in term neonates born elective Lscs with clear liquor

Ashokraja

Balasankar

Mathiarasan

2017

Int J Contemp Pediatr

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“…One randomized study showed significantly lower oxygen saturations in the first 6 min of life in infants routinely suctioned compared to those with no suction [30]. It has recently been shown that wiping the mouth and nose at birth with a cloth in infants >35 weeks of gestation was as efficient as suctioning when the outcome measure was respiratory rate in the first 24 h of life [31]. Vigorous infants with meconium aspiration do not need to be routinely suctioned [7].…”

Section: Suctioning or Wipingmentioning

confidence: 99%

Delivery Room Management of Term and Preterm Newly Born Infants

Saugstad¹

2015

Neonatology

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Delivery room management, especially in the first ‘golden' minute, is of the utmost importance. An exact and universal definition of when a baby is born is needed to obtain agreement on what is meant by the first minute of life. Education of young girls is a basic requirement to optimize the health of the mother and baby. Interventions in pregnancy should as far as possible be evidence based. Antenatal care, the selection of birth mode and antenatal steroid therapy when indicated also contribute to obtaining the best outcome. Delayed cord clamping is recommended for both preterm and term infants. However, more data are needed regarding the most immature infants. Routine suctioning of the mouth and airways is not required. Thermal control is important - keep the temperature in the delivery room at 26°C and wrap infants <28 weeks of gestation in plastic. However, this procedure does not reduce mortality. Since delayed cord clamping increases mean birth weight by approximately 30 g/kg, the present birth weight charts based on early clamping need to be corrected. Preterm infants in need of ventilatory support should start with CPAP from the first breath. A T-piece device seems to have some advantages compared to self-inflating bags. Surfactant instillation is often not needed prophylactically provided the mother has received antenatal steroids. Less invasive methods for administering surfactant may be useful. If ventilatory support is needed, start with air in term and near-term infants. For babies of 29-33 weeks of gestation start with 21-30% oxygen and for infants <29 weeks start with 30% oxygen and adjust according to the response obtained.

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“…Because MSAF is often first identified shortly before delivery, a trial of reasonable length would require seeking consent from all women in labor at $35 weeks' gestation. Yet very few of them, #3% in a recent study, 9 deliver nonvigorous infants with MSAF. This approach to consent would impose unreasonable personnel time and cost per infant enrolled and intrude on many laboring women who would not need and may not want the information provided.…”

Section: Comments By Dr Susan Wootton Dr Cody Arnold and Dr Jon Tysonmentioning

confidence: 99%

When Is Waiver of Consent Appropriate in a Neonatal Clinical Trial?

et al. 2014

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It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.

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Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial

Cited by 55 publications

References 13 publications

A Randomised controlled equivalency trial on wiping with a cloth (no suction) versus routine suctioning of oronasopharynx at birth, in term neonates born elective Lscs with clear liquor

A Randomised controlled equivalency trial on wiping with a cloth (no suction) versus routine suctioning of oronasopharynx at birth, in term neonates born elective Lscs with clear liquor

Delivery Room Management of Term and Preterm Newly Born Infants

When Is Waiver of Consent Appropriate in a Neonatal Clinical Trial?

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