Effect of Nurse Led Developmental Intervention Packages on Neurodevelopmental Outcome of Preterm babies in AIIMS, Jodhpur.

Phase 3

Not yet recruiting

• Conditions: Preterm [premature] newborn [other],

• Registration Number: CTRI/2022/03/040781
• Lead Sponsor: Raghu V A

Brief Summary

This is a Randomized, open-label, parallel-group single-center trial to compare the efficacy of Nurse-Led developmental intervention packages on the neurodevelopmental outcome of preterm babies in AIIMS, Jodhpur at 9 months of corrected age among 220 preterm babies born less than 36 weeks of gestational age admitted in NICU. The primary outcome of the study is cognitive, motor, language, and socioemotional development of preterm babies as assessed by Bayley Infant and Toddler developmental scale, Edition III at 3 months, 6 months and 9 months follow up.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-05
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Babies born Less than 36 weeks of GA.
• Babies who are admitted to the AIIMS hospital Jodhpur 3.
• Preterm baby admitted in NICU for more than 5 days.

Exclusion Criteria

• Preterm babies with congenital anomalies and who require surgical treatment at birth.
• TORCH Infection 3.
• Inborn Error of Metabolism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome variables are cognitive, motor development, language development and social –emotional development of preterm babies at 9-months corrected age as it is assessed by Bayley Scales of Infant and Toddler Development Third Edition.	3 Months 6 Months and 9 Months corrected age

Secondary Outcome Measures

Name	Time	Method
1. Factors associated with Neurodevelopmental outcome of preterm babies	2. Parental satisfaction with Neurodevelopmental supportive care.

Trial Locations

Locations (1)

All India Institute of Medical sciences, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

All India Institute of Medical sciences, Jodhpur

🇮🇳Jodhpur, RAJASTHAN, India

Raghu V A

Principal investigator

8447007616

raghuva84@gmail.com