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Effect of prone positioning on duration of respiratory support in preterm neonates

Effect of prone positioning on duration of respiratory support in preterm neonates -A randomizedcontrolled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037183
Enrollment
126
Registered
2021-10-08
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: P84- Other problems with newborn

Interventions

Intervention1: Prone positioning in preterm neonates receiving non-invasive respiratory support: Participants in this group will be ventilated predominantly in prone position with each session lasting

Sponsors

Dr Suksham Jain
Lead Sponsor
Dr Suksham Jain
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: All neonates born in the hospital who fulfil the following criteria will be enrolled: 1. Gestation age at birth -280/7 to 336/7 weeks 2. Non-invasive ventilation [Continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV)] as primary mode of respiratory support, including those extubated within first 6 hours of life or as secondary mode, in whom invasive support has been taken off after first 6 hours of life, but not later than 7 days. 3. Within 6 hours of starting non-invasive ventilation

Exclusion criteria

Exclusion criteria: Exclusion criteria: Neonates with following conditions will be excluded: 1. Neonates extubated from high frequency ventilation after 24 hours 2. Mechanical ventilation for more than 7 days 3. Clinical conditions which make impossible to maintain prone position: a) Intraventricular hemorrhage (IVH) grade III or above before randomization b) Neonatal encephalopathy grade II or above c) Umbilical venous catheter (UVC)/umbilical arterial catheter (UAC) in situ d) Electroencephalographic (EEG) monitoring 4. Major congenital malformation 5. Pulmonary air leaks 6. Persistent pulmonary hypertension of newborn

Design outcomes

Primary

MeasureTime frame
Total duration of non-invasive respiratory supportTimepoint: At discharge

Secondary

MeasureTime frame
1. Total duration of any oxygen support 2. Failure of non-invasive ventilation 3. Maximum positive inspiratory pressure(PIP) requirement 4. Maximum positive end expiratory pressure (PEEP) requirement 5. Maximum Mean airway pressure requirement 6. Maximum Fio2 requirement 7. Duration of apnoea 8. Frequency of apnoea 9. Duration of NICU stay 10. Duration of hospital stay. 11. Ease of nursing in prone position (Satisfaction on Likertâ??s scale) Timepoint: 1. During hospital stay 2. During NICU stay 3. During NICU stay 4. During NICU stay 5. During NICU stay 6. During NICU stay 7. During NICU stay 8. During NICU stay 9. At discharge from NICU 10. At discharge from hospital 11. Frequently during the NICU stay

Countries

India

Contacts

Public ContactAtul kumar Jha

Government medical college and hospital,

dr.sukshamj@gmail.com9988901596

Outcome results

None listed

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