search
Back to results

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

Primary Purpose

Mechanical Ventilation, Retinal Disease, Death

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
CPAP
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mechanical Ventilation focused on measuring Preterm infants, Nasal CPAP, Delivery room, Newborn

Eligibility Criteria

1 Minute - 15 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Inborn.

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

Exclusion Criteria:

  • Necessity of intubation
  • Maternal decision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Routine

    CPAP-DR

    Arm Description

    Routine protocol of the service

    Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life

    Outcomes

    Primary Outcome Measures

    Necessity of mechanical ventilation and surfactant during the first 5 days of life

    Secondary Outcome Measures

    Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life
    Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis
    Oxygen use
    Oxygen use
    Oxygen use
    Retinopathies of prematurity
    Death during hospitalization

    Full Information

    First Posted
    November 27, 2009
    Last Updated
    December 21, 2009
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01024361
    Brief Title
    Cpap at Delivery Room for Preterm Infants
    Acronym
    CPAP-DR
    Official Title
    CPAP Application at Delivery Room at Very Low Birth Weight Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2009 (Anticipated)
    Study Completion Date
    December 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mechanical Ventilation, Retinal Disease, Death, Respiratory Tract Disease
    Keywords
    Preterm infants, Nasal CPAP, Delivery room, Newborn

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Routine
    Arm Type
    No Intervention
    Arm Description
    Routine protocol of the service
    Arm Title
    CPAP-DR
    Arm Type
    Experimental
    Arm Description
    Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life
    Intervention Type
    Device
    Intervention Name(s)
    CPAP
    Other Intervention Name(s)
    Neopuff
    Intervention Description
    CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff
    Primary Outcome Measure Information:
    Title
    Necessity of mechanical ventilation and surfactant during the first 5 days of life
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life
    Time Frame
    15 minutes
    Title
    Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis
    Time Frame
    30 days
    Title
    Oxygen use
    Time Frame
    28 days
    Title
    Oxygen use
    Time Frame
    56 days
    Title
    Oxygen use
    Time Frame
    36 weeks of corrected age
    Title
    Retinopathies of prematurity
    Time Frame
    Hospital stay
    Title
    Death during hospitalization
    Time Frame
    Hospital stay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Minute
    Maximum Age & Unit of Time
    15 Minutes
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:Inborn. Birth weight 1000g to 1500g No major malformations Exclusion Criteria: Necessity of intubation Maternal decision
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco E Martinez, MD
    Organizational Affiliation
    University of sao Paulo at Ribeirão Preto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cpap at Delivery Room for Preterm Infants

    We'll reach out to this number within 24 hrs