A Phase 4 interventional study of CPAP in Mechanical Ventilation, Retinal Disease and Death, sponsored by University of Sao Paulo. Status unknown. Open to participants aged 1 Minute to 15 Minutes. Per ClinicalTrials.gov, last updated 2009-12-23.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Prevention
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.
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
617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 381 interventional studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:Inborn.
Exclusion Criteria:
Routine protocol of the service
Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life
Device: CPAP
CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff
Also known as: Neopuff
Necessity of mechanical ventilation and surfactant during the first 5 days of life
Time frame: 5 days
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
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo