Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-44
SponsorVilnius University

About this trial

Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome.

Secondary objective is to compare different respiratory support mode performance in different gestational age groups.

Primary endpoint is treatment failure.

With this study, the following hypotheses will be tested:

Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).

Need of respiratory support (deemed by a clinician).

Disqualifiers

Major congenital anomalies

Cardiovascular instability

Consent refused or not provided

Trial design

Design model

Parallel

Treatments tested in this trial

  • NIPPV

    Other intervention

    NIPPV * PEEP 6-8 cmH2O * PIP: 14-16 cmH2O * Tinsp: 0.3-0.5sec * \<28 weeks GA: 0.3 - 0.4 sec * \>28weeks GA: 0.4 - 0.5 sec * Rate: 20-35 breaths per minute.

  • CPAP

    Other intervention

    CPAP pressure of 6-8 mmH2O

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: CPAPActive comparator 1 intervention
Group B: NIPPVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure

Need of intubation

Time frame
7 days

Secondary outcomes

1

Secondary outcomes

Mortality rate

Time frame
44 weeks corrected gestational age
2

Secondary outcomes

Intubation rate

Time frame
7 days
3

Secondary outcomes

Late onset sepsis (LOS) rate

Time frame
44 weeks corrected gestational age
4

Secondary outcomes

Treatment duration

Time frame
44 weeks corrected gestational age

Other outcomes

Sponsors and contacts

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