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A trial comparing between bubble Continuous Positive Airway Pressure and jet Continuous Positive Airway Pressure as method of giving Continuous Positive Airway Pressure in respiratory distress in preterm baby less than 34 weeks of gestation

Jet Continuous Positive Airway Pressure versus Bubble Continuous Positive Airway Pressure in Preterm Babies with Respiratory Distress: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/10/002078
Enrollment
100
Registered
2011-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- preterm baby less than 34 weeks of gestation with respiratory distress onset less than 6 hours of life

Interventions

Intervention1: Jet- conitnous positive airway pressure (J-CPAP): The J-CPAP group will be started on jet CPAP which has a modified Benveniste valve device (Phoenix Medical Technologies Ltd.) with shor

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All inborn neonates of gestational age less than 34 weeks 2. Respiratory distress (defined as presence of at least two out of three signs: tachypnea more than 60/minute, intercostal and/or subcostal retractions, and expiratory grunt) 3. Onset of respiratory distress within 6 hours of life. 4. Baby can be shifted to Neonatal Intensive Care Unit within 12 hours of life

Exclusion criteria

Exclusion criteria: 1. Infants who are intubated soon after birth 2. 5 minute Apgar score less than/ equal to 3 3. Life threatening congenital malformations 4. Conditions were Continouus Positive Airway Pressure is absolutely contraindicated: poor spontaneous respiratory efforts or apnea, worsening shock, suspected or proven persistent pulmonary hypertension of newborn, severe metabolic acidosis (pH -10), severe respiratory acidosis (pH 55mm Hg), massive pulmonary hemorrhage, malformations like congenital diaphragmatic hernia, trachea-esophageal fistula, Pierre-Robinson syndrome, and choanal atresia 5. Parents not willing for neonatal intensive care unit (NICU) care and hence refused consent 6. Non availability of bed in NICU within 12 hours of life 7. If at least one each of the CPAP delivery devices is not available in NICU â??

Design outcomes

Primary

MeasureTime frame
Failure of CPAP in first 72 hours of life Timepoint: 72 hours of life

Secondary

MeasureTime frame
1.Failure of CPAP within 7 days 2.Duration of CPAP support 3.Duration of oxygen Timepoint: 7 day of life;1.Nasal trauma (all severity) 2.Nasal trauma of moderate and severe degree of severity 3. Frequency of dislodgements 4. Pain scoreTimepoint: Till discharge;1.Pulmonary air leaks 2.CPAP Belly 3.Death during hospital stay 4.Proven and probable sepsis 5.Complications of prematurity: chronic lung disease (marked by the need for supplemental oxygen at 36 weeks? postmenstrual age), intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, patent ductus arteriosus (clinical and/or echo proven) Timepoint: till discharge

Countries

India

Contacts

Public ContactAnuj Bhatti

PGIMER Chandigarh

bhatti.anuj@gmail.com9914208099

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026