Cpap at Delivery Room for Preterm Infants

CPAP Application at Delivery Room at Very Low Birth Weight Infants

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01024361

Acronym

CPAP-DR

Enrollment

200

Registered

2009-12-02

Start date

2009-01-31

Completion date

2010-12-31

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Mechanical Ventilation, Respiratory Tract Disease, Retinal Disease

Keywords

Preterm infants, Nasal CPAP, Delivery room, Newborn

Brief summary

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

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

Interventions

DEVICECPAP

CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 15 Minutes

Healthy volunteers

Inclusion criteria

Inborn. * Birth weight 1000g to 1500g * No major malformations

Exclusion criteria

* Necessity of intubation * Maternal decision

Design outcomes

Primary

Measure	Time frame
Necessity of mechanical ventilation and surfactant during the first 5 days of life	5 days

Secondary

Measure	Time frame
Retinopathies of prematurity	Hospital stay
Death during hospitalization	Hospital stay
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026