Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIPPV, CPAP.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome (RDS). Basic parameters: 0 Minutes — 44 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lithuania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
Overview
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.
Detailed description
Treatment failure is defined as any of the following:
* FiO2\>0.6 to maintain SpO2\>88% * Respiratory acidosis (pH\<7.2, pCO2\>65 mmHg) * recurrent apnea (\>4 episodes/h) or apnea requiring bag and mask ventilation * Silverman Andersen respiratory severity score (SAS score) ≥6 and does not improve by \> 20% within 4-8 hours
Secondary endpoints:
* Mortality rate * Intubation rate * Late onset sepsis (LOS) rate * Treatment duration * Complication rates:
Pneumothorax rate Bronchopulmonary dysplasia (BPD) Necrotizing enterocolitis (NEC) Persisting ductus arteriosus (PDA) Intraventricular hemorrhage (IVH) Retinopathy of prematurity (ROP)
Nasal trauma:
* I° - nasal/septal redness * II° - nasal/septal redness + indent * III° - nasal/septal redness + indent + skin breakdown
Abdominal distension:
* Visible abdominal distension (defined by attending clinician) AND one of the following: * Feeding intolerance (defined by clinician) OR * \>3 desaturation episodes or \>20% FiO2 increase in 1 hour after feed.
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.
Interventions
- Other NIPPV
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. - Other CPAP
CPAP pressure of 6-8 mmH2O
Primary outcome measures
- Treatment failure [Time frame: 7 days]
Secondary outcome measures (5)
- Secondary outcomes [Time frame: 44 weeks corrected gestational age]
- Secondary outcomes [Time frame: 7 days]
- Secondary outcomes [Time frame: 44 weeks corrected gestational age]
- Secondary outcomes [Time frame: 44 weeks corrected gestational age]
- Secondary outcomes [Time frame: 44 weeks corrected gestational age]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Lithuania · 1 center
- Vilnius University Santaros Klinikos — Vilnius
Identifiers
NCT: NCT06966752 · NC3