NCT03670732: NICA

CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

Terminated NA Last updated 30 July 2024

What this trial tests

NA trial testing continuous positive airway pressure in Prematurity in 52 participants. Terminated before completion.

Timeline

30 September 2017

Primary endpoint
30 March 2020

30 June 2020

Quick facts

Lead sponsor	Women and Infants Hospital of Rhode Island
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	30 September 2017
Primary completion	30 March 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• continuous positive airway pressure
• nasal intermittent positive pressure ventilation

Conditions studied

• Prematurity — all drugs for Prematurity →
• Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →
• Apnea of Prematurity — all drugs for Apnea of Prematurity →

Sponsor

Women and Infants Hospital of Rhode Island

Who can join

Under 6 Months, any sex, with Prematurity or Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants.
   Lemyre B, Deguise MO, Benson P, Kirpalani H, et al · · 2023 · cited 21× · PMID 37466143 · DOI 10.1002/14651858.cd005384.pub3