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Randomized Controlled Trial Multicenter Study Clinical Trial
Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial.
- Nestor E Vain, Edgardo G Szyld, Luis M Prudent, Thomas E Wiswell, Adriana M Aguilar, and Norma I Vivas.
- Sanatorio de la Trinidad Hospitals, Buenos Aires, Argentina. vain@fibertel.com.ar
- Lancet. 2004 Aug 14;364(9434):597-602.
BackgroundMeconium aspiration syndrome (MAS) is a life-threatening respiratory disorder in infants born through meconium-stained amniotic fluid (MSAF). Although anecdotal data concerning the efficacy of intrapartum oropharyngeal and nasopharyngeal suctioning of MSAF are conflicting, the procedure is widely used. We aimed to assess the effectiveness of intrapartum suctioning for the prevention of MAS.MethodsWe designed a randomised controlled trial in 11 hospitals in Argentina and one in the USA. 2514 patients with MSAF of any consistency, gestational age at least 37 weeks, and cephalic presentation were randomly assigned to suctioning of the oropharynx and nasopharynx (including the hypopharynx) before delivery of the shoulders (n=1263), or no suctioning before delivery (n=1251). Postnatal delivery-room management followed Neonatal Resuscitation Program guidelines. The primary outcome was incidence of MAS. Clinicians diagnosing the syndrome and designating other study outcomes were masked to group assignment. An informed consent waiver was used. Analysis was by intention to treat.Findings18 infants in the suction group and 15 in the no suction group did not meet entry criteria after random assignment. 87 in the suction group were not suctioned, and 26 in the no suction group were suctioned. No significant difference between treatment groups was seen in the incidence of MAS (52 [4%] suction vs 47 [4%] no suction; relative risk 0.9, 95% CI 0.6-1.3), need for mechanical ventilation for MAS (24 [2%] vs 18 [1%]; 0.8, 0.4-1.4), mortality (9 [1%] vs 4 [0.3%]; 0.4, 0.1-1.5), or in the duration of ventilation, oxygen treatment, and hospital care.InterpretationRoutine intrapartum oropharyngeal and nasopharyngeal suctioning of term-gestation infants born through MSAF does not prevent MAS. Consideration should be given to revision of present recommendations.
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