NCT01294852

Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 1 Minute – 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.

Detailed description

Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.

Conditions

• Premature Birth
• Premature Lungs

Interventions

Type	Name	Description
OTHER	surfactant prophylaxis	Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf\[Chiesi, Farmaceutici, Parma, Italy\]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf\[Chiesi, Farmaceutici, Parma, Italy\]).

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2011-02-14
• Last updated: 2011-06-22

Locations

1 site across 1 country: Turkey (Türkiye)