Comparing two methods of giving support to respiratory system of babies born early , following the removal of respiratory support which was being provided through a tube placed in babys airway
Not Applicable
Completed
- Conditions
- Health Condition 1: P229- Respiratory distress of newborn, unspecified
- Registration Number
- CTRI/2019/07/020055
- Lead Sponsor
- Department of Neonatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
1. Infants born between 26 weeks of gestation and <= 37 weeks of gestation and birth weight between 500 grams to 2500 grams
2. Inborn babies upto postnatal age 15 days
3. Mechanically ventilated for at least 12 hrs
Exclusion Criteria
1.Babies < 26 weeks gestational age at birth and > 37 weeks of gestation and < 500
gms
2. Outborn babies
3. Major congenital anomalies or known/suspected chromosomal anomalies
4. Upper airway anomalies
5. Severe perinatal asphyxia ( blood gas pH less than 7.0 and BE more than -12 )
6. Participation in another randomized interventional trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Extubation failure within 72 hoursTimepoint: 72 hours
- Secondary Outcome Measures
Name Time Method ALL CAUSE MORTALITYTimepoint: TILL DISCHARGE;BPDTimepoint: till discharge;INVASIVE VENTILATOR DAYSTimepoint: TILL DISCHARGE;IVH GRADE 3 AND ABOVE (on TcUSG)Timepoint: TILL DISCHARGE;NEC STAGE 2 AND ABOVE, GASTROINTESTINAL PERFORATION( confirmed on xray or surgical exploration), ABDOMINAL DISTENSION more than 2cm (necessitating cessation of feeding in first 48 hours post extubation)Timepoint: till discharge;NICU LENGTH OF STAYTimepoint: TILL DISCHARGE;PULMONARY AIR LEAKTimepoint: TILL RESPIRATORY SUPPORT REQUIREMENT;ROP, ANY STAGETimepoint: TILL DISCHARGE