Cpap at Delivery Room for Preterm Infants

Study Overview
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Brief Summary
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The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.

Detailed Description
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A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs

Official Title
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CPAP Application at Delivery Room at Very Low Birth Weight Infants

Conditions
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Mechanical Ventilation, Retinal Disease, Death, Respiratory Tract Disease

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Inborn. Birth weight 1000g to 1500g No major malformations Exclusion Criteria: Necessity of intubation Maternal decision

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 15 Minutes

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine<br>Routine protocol of the service | |
| Experimental: CPAP-DR<br>Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life | Device: CPAP<br>* CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff<br>* Other names: Neopuff;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necessity of mechanical ventilation and surfactant during the first 5 days of life |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life |  | 15 minutes | 
| Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis |  | 30 days | 
| Oxygen use |  | 28 days | 
| Oxygen use |  | 56 days | 
| Oxygen use |  | 36 weeks of corrected age | 
| Retinopathies of prematurity |  | Hospital stay | 
| Death during hospitalization |  | Hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm infants, Nasal CPAP, Delivery room, Newborn