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Cpap at Delivery Room for Preterm Infants (CPAP-DR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01024361
First received: November 27, 2009
Last updated: December 21, 2009
Last verified: December 2009

November 27, 2009
December 21, 2009
January 2009
December 2009   (final data collection date for primary outcome measure)
Necessity of mechanical ventilation and surfactant during the first 5 days of life [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024361 on ClinicalTrials.gov Archive Site
  • Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Oxygen use [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Oxygen use [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Oxygen use [ Time Frame: 36 weeks of corrected age ] [ Designated as safety issue: No ]
  • Retinopathies of prematurity [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]
  • Death during hospitalization [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]
  • Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Oxygen use [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Oxygen use [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Oxygen use [ Time Frame: 36 weeks of corrected age ] [ Designated as safety issue: No ]
  • Retinopathies of prematurity [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]
  • All cause Mortality [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cpap at Delivery Room for Preterm Infants
CPAP Application at Delivery Room at Very Low Birth Weight Infants

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Mechanical Ventilation
  • Retinal Disease
  • Death
  • Respiratory Tract Disease
Device: CPAP
CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff
Other Name: Neopuff
  • No Intervention: Routine
    Routine protocol of the service
  • Experimental: CPAP-DR
    Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life
    Intervention: Device: CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:Inborn.

  • Birth weight 1000g to 1500g
  • No major malformations

Exclusion Criteria:

  • Necessity of intubation
  • Maternal decision
Both
up to 15 Minutes
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01024361
120789, FAPESP 06/61388-2
Yes
Francisco Eulogio Martinez/ Professor Titular, University of Sao Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Francisco E Martinez, MD University of sao Paulo at Ribeirão Preto
University of Sao Paulo
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP