The study to compare two ways of helping premature babies stop using Non -invasive breathing support .ONE METHOD will be gradual reduce the support while the other method would be to stop the support suddenly .
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2024/07/069733
- Lead Sponsor
- niversity College of Medical Sciences AND GTB HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All preterm neonates (28 to 36 week) on NIV Support and met the weaning readiness criteria .
1. Clinically stable neonate on NIV,PEEP of less than equal to 6cm H2O,Fio2 less than equal to 0.35percent, Maintaining Spo2 90-95percent for a minimum of 12 hours.
2. Normal work of breathing:no persistent tachypnea (more than 60 breaths for more than 2hr ),no marked retractions .
3. Hemodynamically stable .
4.NO APNEA associated with bradycardia or cyanosis with more than 2 episode in 12hr or more than 3 in 24hr with at least one requiring bag and mask ventilation .
5.Not currently treated for Patent ductus arteriosus.
6.Tolerated time off NIV during nursing cluster care for up to 5 to 10 minutes.
7. Pip of less than equal to 15 cm H20 and backup respiratory rate of less than equal to 50 percent of total respiratory rate.
2.
Preterm neonates with chromosomal defects and severe congenital anomalies including congenital heart disease , neurological malformations , chest wall or airway abnormalities and lung hypoplasia .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group.Timepoint: Randomization to off oxygen for 3 days
- Secondary Outcome Measures
Name Time Method 1. Mean post -menstrual age at the time of successful wean in both the group. <br/ ><br>2. Mean weight at time of successful wean in both the group. <br/ ><br>3.Total duration of NIV Support in successfully weaned preterm neonates of each group . <br/ ><br>4.Length of stay (LOS) in NICU in successfully weaned preterm neonates of each group .Timepoint: 1.Randomization to off oxygen for 3 days . <br/ ><br>2.Randomization to off oxygen for 3 days. <br/ ><br>3.Date from patient require NIV to Off NIV support. <br/ ><br>4 Date of admission to Date of discharge/death/lama/abscond/refered to another hospital.