Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

Comparing the Effects of Bubble Nasal CPAP Versus Ventilator Nasal CPAP in Preterm Infants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02003846

Enrollment

Registered

2013-12-06

Start date

2013-11-30

Completion date

2014-10-31

Last updated

2015-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Brief summary

There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted. The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

Detailed description

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Days to 3 Months

Healthy volunteers

Inclusion criteria

* Neonates between 26-32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of \< or = 0.3. Parental consent will be obtained prior to enrollment.

Exclusion criteria

* Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.

Design outcomes

Primary

Measure	Time frame	Description
Physiologic parameters	2 hours	heart rate, respiratory rate, oxygen saturation

Secondary

Measure	Time frame	Description
Physiologic parameters	2 hours	cerebral oxygen tissue extraction

Countries

United States

Outcome results