MedDataX Logo

Cpap at Delivery Room for Preterm Infants

NCT ID: NCT01024361

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation Retinal Disease Death Respiratory Tract Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Preterm infants Nasal CPAP Delivery room Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine

Routine protocol of the service

Group Type NO_INTERVENTION

No interventions assigned to this group

CPAP-DR

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

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPAP

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neopuff

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Necessity of intubation
* Maternal decision
Minimum Eligible Age

1 Minute

Maximum Eligible Age

15 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Sao Paulo

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francisco E Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

University of sao Paulo at Ribeirão Preto

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FAPESP 06/61388-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

120789

Identifier Type: -

Identifier Source: org_study_id