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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Death; Retinal Disease; Mechanical Ventilation; Respiratory Tract Disease

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01024361

120789

FAPESP 06/61388-2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 15 minutes old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Inborn.

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

Exclusion Criteria:

• Necessity of intubation
• Maternal decision

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Routine

No Intervention group

Description:

Routine protocol of the service

CPAP-DR

Experimental group

Description:

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

Treatment:

Device: CPAP