Premature Birth, Premature Lungs
Conditions
Keywords
prophylactic, surfactant, premature, mechanical ventilation, mortality, morbidities
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.
Interventions
OTHERsurfactant 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\[Chiesi, Farmaceutici, Parma, Italy\]).
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pulmonary hemorrhage | first 72 hours of life |
| patent ductus arteriosus | first one week |
| necrotizing enterocolitis | first one month |
| retinopathy of prematurity | first two months |
| Pneumothorax | first 72 hours of life |
| bronchopulmonary dysplasia | first two months |
| duration of hospitalization | one year |
| mortality | one year |
| intraventricular hemorrhage | first one week |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSaadet Arsan, Professor
Backup ContactEmel Okulu, MD
Outcome results
None listed