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

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ClinicalTrials.gov Identifier: NCT01024361
Recruitment Status : Unknown
Verified December 2009 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : December 2, 2009
Last Update Posted : December 23, 2009
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Retinal Disease Death Respiratory Tract Disease Device: CPAP Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CPAP Application at Delivery Room at Very Low Birth Weight Infants
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Necessity of mechanical ventilation and surfactant during the first 5 days of life [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life [ Time Frame: 15 minutes ]
  2. Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis [ Time Frame: 30 days ]
  3. Oxygen use [ Time Frame: 28 days ]
  4. Oxygen use [ Time Frame: 56 days ]
  5. Oxygen use [ Time Frame: 36 weeks of corrected age ]
  6. Retinopathies of prematurity [ Time Frame: Hospital stay ]
  7. Death during hospitalization [ Time Frame: Hospital stay ]

Eligibility Criteria
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Ages Eligible for Study:   up to 15 Minutes   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024361


Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Francisco E Martinez, MD University of sao Paulo at Ribeirão Preto
More Information
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Responsible Party: Francisco Eulogio Martinez/ Professor Titular, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01024361    
Other Study ID Numbers: 120789
FAPESP 06/61388-2 ( Other Grant/Funding Number: FAPESP 06/61388-2 )
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009
Keywords provided by University of Sao Paulo:
Preterm infants
Nasal CPAP
Delivery room
Newborn
Additional relevant MeSH terms:
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Respiratory Tract Diseases
Retinal Diseases
Eye Diseases