Short-term and long-term outcomes of â??Developmental and Supportive Care Interventions Bundleâ?? in preterm neonates
Not Applicable
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2022/12/047815
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Inborn pre-term neonates with gestational age of less than 32 weeks.
2. Inborn pre-term neonates admitted in NICU within 7 days of birth.
3. Parents of inborn pre-term neonates residing in or within 100km radius of Chandigarh and are willing to come for follow up for at least 2 years after discharge
Exclusion Criteria
•Major congenital malformations.
•Syndromic neonates
•Proven intrauterine infection
•Sever perinatal asphyxia (APGAR score at 5 min is 0-3)
•Known case of visual and hearing abnormality diagnosed prior to enrolment.
•Pre-tern neonates whose mother has died or mentally impaired or not willing to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite adverse outcome which includes death and Neurodevelopmental impairment after discharge within first 2 years of lifeTimepoint: 2 years
- Secondary Outcome Measures
Name Time Method ong term outcomes: <br/ ><br>â?¢weight at Corrected age of 1 year and 2 years <br/ ><br>â?¢Head Circumference and length at Corrected age of 1 year and 2 years <br/ ><br>â?¢Prevalence of seizure or epilepsy within first 2 years of life <br/ ><br>â?¢Preschool behavior outcomes <br/ ><br>Short term outcomes: <br/ ><br>â?¢Reductions in Stress behavior signs during NICU stay <br/ ><br>â?¢Improvement in â??Infant Positioning Assessment Tool score during NICU stay <br/ ><br>â?¢Weekly Weight gain, weight at discharge. <br/ ><br>â?¢Head Circumference and length at discharge. <br/ ><br>â?¢Transition time from oro-gastric tube feed to spoon feed and from spoon feed to direct breast feed <br/ ><br>Timepoint: 2 years