Clinical Trial: Randomized Clinical Trial Assessing Laryngeal Mask Airway Versus Face-mask Ventilation in Neonatal Resuscitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Trial Assessing Laryngeal Mask Airway (LMA) Versus Face-mask Ventilation (FMV) in Neonatal Resuscitation at Mulago Hospital, Uganda

Brief Summary: The purpose of this study is to compare the use of a laryngeal mask airway (LMA) vs. face-mask ventilation (FMV) during first-line neonatal resuscitation in Mulago Hospital, Kampala, Uganda.

Detailed Summary:

Background: Perinatal mortality in Eastern Uganda 2007/2008 was estimated to 41/1000 pregnancies. The rate of stillbirth was 19/1000. In the whole of Uganda in 2008, neonatal deaths constituted 21% of an estimated 190,000 under five deaths, while HIV constituted only 5%. Implementing a Helping Babies Breathe (HBB) program in one centre in Tanzania resulted in almost 40 % reduction of early neonatal mortality. Introducing a neonatal intervention package even reduced the rate of stillbirths. Birth asphyxia (BA) accounted for 60% of early neonatal deaths in Haydom Lutheran Hospital, Tanzania.

The need for resuscitation is greater in the neonate than in any other age group. Providing effective positive pressure ventilation (PPV) is the single most important component of successful neonatal resuscitation (5). Ventilation is frequently initiated with face-mask ventilation (FMV) followed by endotracheal intubation (ETT) if depression continues. These techniques may be difficult to perform resulting in prolonged resuscitation. The laryngeal mask airway (LMA) may achieve initial ventilation and successful resuscitation faster than a face-mask device or ETT. Various publications and a Cochrane review has shown LMA to be as efficient as ETT. Important air leakage during FMV is an issue. LMA reduces the need for ETT. The latest generation of LMA is made of a medical-grade gel-like elastomer designed to provide an efficient seal to the larynx without an inflatable cuff. The risk for trauma is minimised. Insertion is easy with a low risk of tissue compression or dislodgement. In a study to evaluate educational intervention in the Democratic Republic of Congo, both physicians and midwifes showed a good level of expertise in LMA insertion on mannequins. Both groups almost unanimously manifested a high degree of approval of neonatal resuscitation with LMA.

To assess if the ventilation time needed for neonates with an estimated birth weight of 2 kg or above and in need of initial respiratory support can be decreased from an average of 132 seconds in infants being resuscitated using FMV (control arm) to an average ventilation time of 72 seconds for infants resuscitated with the use of LMA (interventions arm).