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Seven or five - which is the best initial continuous positive airway pressure (CPAP)level to start?

Seven Versus Five cm of water as the initiating level of continuous positive airway pressure in preterm neonates with respiratory distress. A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004539
Enrollment
268
Registered
2014-04-11
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- Respiratory distress

Interventions

Intervention1: Initial CPAP pressure - 7 cm of water: We will initiate CPAP at 7 cm of water to neonates with respiratory distress and then adjust according to clinical condition Control Intervention1

Sponsors

Fernandez Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates fulfilling ALL of these criteria would be eligible for enrolment 1.Born at gestation 2.Having respiratory distress at less than 24 hours of age and requiring CPAP {defined as having tachypnea (respiratory rate >60) and/ or Silverman Anderson Score >=3}.

Exclusion criteria

Exclusion criteria: Neonates with any of the following 1. Major congenital malformation 2. Contra-indication for CPAP ( Poor respiratory drive, choanal atresia, cleft palate) 3. Severe metabolic acidosis 4. On Dopamine or dobutamine > 10 micrograma/kg/min 5. Active seizures 6. APGAR 7. Severe respiratory distress at onset requiring mechanical ventilation

Design outcomes

Primary

MeasureTime frame
CPAP failure (need of mechanical ventilation in the first week of life).Timepoint: CPAP failure (need of mechanical ventilation in the first week of life).

Secondary

MeasureTime frame
Bronchopulmonary dysplasia (BPD) (oxygen dependency at 28 days)Timepoint: 28 days of life;Chronic lung disease (CLD) (oxygen dependency at 36 weeks postmenstrual age)Timepoint: at 36 weeks postmenstrual age;Duration of oxygen requirement (total duration of all types of oxygen therapy)Timepoint: Till discharge;Gastric perforationTimepoint: Till discharge;Hospital stay (time period from admission till discharge)Timepoint: Till discharge;Incidence of airleak syndrome Timepoint: till the neonate on CPAP;Intraventricular hemorrhage (IVH)Timepoint: Till discharge;Late onset sepsis (proven or suspected)Timepoint: Till discharge;Local injury(nasal injury, bleeding)Timepoint: till the neonate on CPAP;Necrotising enterocolitis (NEC)Timepoint: Till discharge;Need of dopamine or dobutamine more than 10 microgram per minuteTimepoint: till the neonate on CPAP;Need of volume expandersTimepoint: till the neonate on CPAP;Nursery stay(time period in NICU)Timepoint: Till transfer to room or discharge;Patent Ductus Arteriosus(PDA)Timepoint: Till discharge;Periventricular leukomalacia(PVL)Timepoint: Till discharge;Retinopathy of prematurity (ROP)Timepoint: Till discharge;Time taken to reach full feeds (150 ml per kg per day)Timepoint: till the time to reach full feeds;Time taken to start feedsTimepoint: Till discharge;Total duration of respiratory supportTimepoint: Till discharge

Countries

India

Contacts

Public ContactDr Srinivas Murki

Fernandez Hospital

premnathani@yahoo.com040-40632440

Outcome results

None listed

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