A study to assess the efficacy of Extended Continuous Positive Airway Pressure in reducing the duration of respiratory support among preterm infants with respiratory problems

To assess the efficacy of Extended Continuous Positive Airway Pressure in reducing the duration of respiratory support among preterm infants with respiratory distress syndromeâ??a pilot randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072697

Enrollment

142

Registered

2024-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Extended CPAP group: Once the stability criteria is reached, CPAP is extended by a minimum of 24 hours, followed by weaning as per standard protocol. Standard weaning protocol is as fol

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age less than 32 weeks treated for respiratory distress syndrome with or without surfactant and meeting the predesignated CPAP stability criteria will be included.

Exclusion criteria

Exclusion criteria: major congenital anomalies, clinical suspicion of congenital pneumonia.

Design outcomes

Primary

Measure	Time frame
Time to wean off initial respiratory support to room air.Timepoint: 1. Baseline (start of intervention) 2. Every 24 hours 3. Specific days (day 3,7,14) 4. At each weaning attempt 5. At successful weaning(24 hours off support) 6. Follow up at 24, 48 hours and 7 days after weaning	—

Secondary

Measure	Time frame
Incidence of bronchopulmonary dysplasia: The study will measure the incidence of bronchopulmonary dysplasia among participantsTimepoint: This is assessed at 36 weeks postmenstrual age;Neonatal mortality : the rate of death among neonates in the study.Timepoint: This is assessed during initial hospital stay & up to 28 days of life.;Length of hospital stay: The duration of hospitalization from birth until discharge.Timepoint: This is assessed from birth until first discharge from the hospital.;Time to full feeds: The period required for participants to achieve full enteral feeding.Timepoint: This is assessed daily from birth until full enteral feeding is achieved.;Time to establish full oral feeding (paladai feeds or breastfeeds, off gavage feeds for more than 48 hours): The time taken to transition to & maintain full oral feeding.Timepoint: This is assessed daily from birth until oral feeding is established;Re-initiation of respiratory support after weaning to room air: The frequency of restarting respiratory support after initial successful weaning to room air. Timepoint: This is assessed from weaning to room air until first discharge from hospital.;Re-intubation during the first week of life: The incidence of re-intubation within the first seven days after birth.Timepoint: This is assessed within the first 7 days of life.	—

Measure

Time frame

Incidence of bronchopulmonary dysplasia: The study will measure the incidence of bronchopulmonary dysplasia among participantsTimepoint: This is assessed at 36 weeks postmenstrual age;Neonatal mortality : the rate of death among neonates in the study.Timepoint: This is assessed during initial hospital stay & up to 28 days of life.;Length of hospital stay: The duration of hospitalization from birth until discharge.Timepoint: This is assessed from birth until first discharge from the hospital.;Time to full feeds: The period required for participants to achieve full enteral feeding.Timepoint: This is assessed daily from birth until full enteral feeding is achieved.;Time to establish full oral feeding (paladai feeds or breastfeeds, off gavage feeds for more than 48 hours): The time taken to transition to & maintain full oral feeding.Timepoint: This is assessed daily from birth until oral feeding is established;Re-initiation of respiratory support after weaning to room air: The frequency of restarting respiratory support after initial successful weaning to room air. Timepoint: This is assessed from weaning to room air until first discharge from hospital.;Re-intubation during the first week of life: The incidence of re-intubation within the first seven days after birth.Timepoint: This is assessed within the first 7 days of life.

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Countries

India

Contacts

Public ContactDr Nishad Plakkal

JIPMER

plakkal@gmail.com7708577133

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026