Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Ankara University

Status

Unknown

Conditions

Premature Lungs

Premature Birth

Treatments

Other: surfactant prophylaxis

Study type

Interventional

Funder types

Other

Identifiers

NCT01294852

Ankara University (Other Grant/Funding Number)

Ankara University-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

1 minute to 2 years old

Volunteers

No Healthy Volunteers

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