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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Mechanical Ventilation
Retinal Disease
Death
Respiratory Tract Disease
 Device: CPAP
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CPAP Application at Delivery Room at Very Low Birth Weight Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Necessity of mechanical ventilation and surfactant during the first 5 days of life [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Device: CPAP
CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff
Other Name: Neopuff

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

  Eligibility

Ages Eligible for Study:   up to 15 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inborn.

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

Exclusion Criteria:

  • Necessity of intubation
  • Maternal decision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024361

Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Francisco E Martinez, MD University of sao Paulo at Ribeirão Preto
  More Information

No publications provided

Responsible Party: Francisco Eulogio Martinez/ Professor Titular, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01024361     History of Changes
Other Study ID Numbers: 120789, FAPESP 06/61388-2
Study First Received: November 27, 2009
Last Updated: December 21, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Preterm infants
Nasal CPAP
Delivery room
Newborn

Additional relevant MeSH terms:
Respiratory Tract Diseases
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013