NCT01024361

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

11 months

First QC Date

November 27, 2009

Last Update Submit

December 21, 2009

Conditions

Mechanical VentilationRetinal DiseaseDeathRespiratory Tract Disease

Keywords

Preterm infantsNasal CPAPDelivery roomNewborn

Outcome Measures

Primary Outcomes (1)

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

    5 days

Secondary Outcomes (7)

  • Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life

    15 minutes

  • Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis

    30 days

  • Oxygen use

    28 days

  • Oxygen use

    56 days

  • Oxygen use

    36 weeks of corrected age

  • +2 more secondary outcomes

Study Arms (2)

Routine

NO INTERVENTION

Routine protocol of the service

CPAP-DR

EXPERIMENTAL

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

Device: CPAP

Interventions

CPAPDEVICE

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

Also known as: Neopuff
CPAP-DR

Eligibility Criteria

Age1 Minute - 15 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Necessity of intubation
  • Maternal decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal DiseasesDeathRespiratory Tract Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francisco E Martinez, MD

    University of sao Paulo at Ribeirão Preto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2009

First Posted

December 2, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

December 23, 2009

Record last verified: 2009-12