Early parent participation compared to conventional care for preterm babies in the NICU â?? A randomized controlled trial

Not Applicable

Completed

• Conditions: Health Condition 1: null- Preterm neonates 28-33 weeks gestation, admitted in the Neonatal Intensive Care Unit of the Institute

• Registration Number: CTRI/2014/07/004757
• Lead Sponsor: KIMS Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 146

Inclusion Criteria

All inborn babies less than or equal to weeks, and outborn babies admitted to NICU within 24 hours of birth

Exclusion Criteria

•Less than 28 weeks gestation

•Major congenital anomalies requiring surgical intervention (identified before enrollment)

•Parents not willing to participate, outborn babies admitted after 24 hours of life or parents requesting referral back out of the hospital before completion of medical care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Number of babies having physiological instability atleast 72 hours after starting parent participation â?? desaturation, feed intolerance and investigation for suspected infection <br/ ><br>â?¢Dominant breast milk feeding rates at discharge <br/ ><br>â?¢Proportion of babies meeting discharge criteria by 34 weeks gestation <br/ ><br>Timepoint: Discharge from hospital

Secondary Outcome Measures

Name	Time	Method
â?¢Hospital associated infection rates <br/ ><br>â?¢Dropout rates after enrollment <br/ ><br>â?¢Stress of parents, nurses and doctors <br/ ><br>â?¢Seeking hospital care within 1 month of discharge <br/ ><br>â?¢Extra-uterine growth retardation â?? weight at discharge and 40 weeks <br/ ><br>â?¢NEC <br/ ><br>â?¢Oxygen dependency at postnatal day 28 <br/ ><br>â?¢Absence of major neurodevelopmental disability at 40 weeks <br/ ><br>ROP requiring treatment <br/ ><br>PVL at 36-40 weeks USG cranium <br/ ><br>â?¢Mortality, all cause in NICU <br/ ><br>Timepoint: 40 weeks gestational age