This trial is active, not recruiting.

Conditions mechanical ventilation, retinal disease, death, respiratory tract disease
Treatment cpap
Phase phase 4
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date January 2009
End date December 2009
Trial size 200 participants
Trial identifier NCT01024361, 120789, FAPESP 06/61388-2


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(No Intervention)
Routine protocol of the service
Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life
cpap Neopuff
CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff

Primary Outcomes

Necessity of mechanical ventilation and surfactant during the first 5 days of life
time frame: 5 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 15 minutes old.

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

Additional Information

Official title CPAP Application at Delivery Room at Very Low Birth Weight Infants
Principal investigator Francisco E Martinez, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo.