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

Tracking Information

First Received Date ^ICMJE

November 27, 2009

Last Updated Date

December 21, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01024361 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cpap at Delivery Room for Preterm Infants

Official Title ^ICMJE

CPAP Application at Delivery Room at Very Low Birth Weight Infants

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Mechanical Ventilation
Retinal Disease
Death
Respiratory Tract Disease

Intervention ^ICMJE

Device: CPAP

CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff

Other Name: Neopuff

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:Inborn.

Birth weight 1000g to 1500g
No major malformations

Exclusion Criteria:

Necessity of intubation
Maternal decision

Gender

Both

Ages

up to 15 Minutes

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01024361

Other Study ID Numbers ^ICMJE

120789, FAPESP 06/61388-2

Has Data Monitoring Committee

Yes

Responsible Party

Francisco Eulogio Martinez/ Professor Titular, University of Sao Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

Principal Investigator:

Francisco E Martinez, MD

University of sao Paulo at Ribeirão Preto

Information Provided By

University of Sao Paulo

Verification Date

December 2009

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

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