Cpap at Delivery Room for Preterm Infants

Mechanical Ventilation Clinical Trial

— CPAP-DR  

Official title:

CPAP Application at Delivery Room at Very Low Birth Weight Infants

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01024361
• Other study ID #: 120789
• Secondary ID: FAPESP 06/61388-
• Status: Unknown status
• Phase: Phase 4
• First received: November 27, 2009
• Last updated: December 21, 2009
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Minutes

Eligibility

Inclusion Criteria:Inborn.

• Birth weight 1000g to 1500g

• No major malformations

Exclusion Criteria:

• Necessity of intubation

• Maternal decision

Related Conditions & MeSH terms

• Death
• Mechanical Ventilation
• Respiratory Tract Disease
• Respiratory Tract Diseases
• Retinal Disease
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Necessity of mechanical ventilation and surfactant during the first 5 days of life		5 days
Secondary	Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life		15 minutes
Secondary	Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis		30 days
Secondary	Oxygen use		28 days
Secondary	Oxygen use		56 days
Secondary	Oxygen use		36 weeks of corrected age
Secondary	Retinopathies of prematurity		Hospital stay
Secondary	Death during hospitalization		Hospital stay