Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Not Applicable

• Conditions: Premature Birth; Premature Lungs
• Interventions: Other: surfactant prophylaxis

• Registration Number: NCT01294852
• Lead Sponsor: Ankara University

Brief 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.

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-01
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22
• Primary Completion: 2012-01
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Premature infants born before 28 weeks' gestation
• Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery

Exclusion Criteria

• Infants died at delivery room

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate bolus surfactant	surfactant prophylaxis	-
post-resuscitation surfactant	surfactant prophylaxis	-

Primary Outcome Measures

Name	Time	Method
ventilatory requirement	within the first 5 days of life	Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization.

Secondary Outcome Measures

Name	Time	Method
mortality	one year
bronchopulmonary dysplasia	first two months
duration of hospitalization	one year
patent ductus arteriosus	first one week
retinopathy of prematurity	first two months
intraventricular hemorrhage	first one week
Pneumothorax	first 72 hours of life
Pulmonary hemorrhage	first 72 hours of life
necrotizing enterocolitis	first one month

Trial Locations

Locations (1)

Ankara University Faculty of Medicine Department of Pediatrics; 🇹🇷 Ankara, Turkey