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

Not Applicable

Conditions: Health Condition 1: P84- Other problems with newborn

Registration Number: CTRI/2021/10/037183

Lead Sponsor: Dr Suksham Jain

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total duration of non-invasive respiratory supportTimepoint: At discharge

Secondary Outcome Measures

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