Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Birth, Premature Lungs

Intervention / Treatment
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* Other: surfactant prophylaxis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate bolus surfactant<br> | Other: surfactant prophylaxis<br>* 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]).<br>|
| Experimental: post-resuscitation surfactant<br> | Other: surfactant prophylaxis<br>* 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]).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilatory requirement | 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. | within the first 5 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumothorax |  | first 72 hours of life | 
| Pulmonary hemorrhage |  | first 72 hours of life | 
| patent ductus arteriosus |  | first one week | 
| necrotizing enterocolitis |  | first one month | 
| retinopathy of prematurity |  | first two months | 
| intraventricular hemorrhage |  | first one week | 
| bronchopulmonary dysplasia |  | first two months | 
| duration of hospitalization |  | one year | 
| mortality |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prophylactic, surfactant, premature, mechanical ventilation, mortality, morbidities