Clinical trial NCT01294852: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
Official title: A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Premature Lungs
Keywords: prophylactic
surfactant
premature
mechanical ventilation
mortality
morbidities
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: ventilatory requirement
timeFrame: within the first 5 days of life
Secondary outcomes:
measure: Pneumothorax
timeFrame: first 72 hours of life
measure: Pulmonary hemorrhage
timeFrame: first 72 hours of life
measure: patent ductus arteriosus
timeFrame: first one week
measure: necrotizing enterocolitis
timeFrame: first one month
measure: retinopathy of prematurity
timeFrame: first two months
measure: intraventricular hemorrhage
timeFrame: first one week
measure: bronchopulmonary dysplasia
timeFrame: first two months
measure: duration of hospitalization
timeFrame: one year
measure: mortality
timeFrame: one year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine Department of Pediatrics
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Saadet Arsan, Professor
role: STUDY_DIRECTOR
affiliation: Ankara University Faculty of Medicine
name: Emel Okulu, MD
role: PRINCIPAL_INVESTIGATOR
References: