Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003846
• Other study ID #: MMC 2013-02-10
• Secondary ID: MMC 2013-02-10
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: June 27, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. — View Citation

Lee KS, Dunn MS, Fenwick M, Shennan AT. A comparison of underwater bubble continuous positive airway pressure with ventilator-derived continuous positive airway pressure in premature neonates ready for extubation. Biol Neonate. 1998;73(2):69-75. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiologic parameters	heart rate, respiratory rate, oxygen saturation	2 hours	No
Secondary	Physiologic parameters	cerebral oxygen tissue extraction	2 hours	No