A Clinical trial to study the effect of nurture on premature neonates.

Not Applicable

Completed

• Conditions: Health Condition 1: P011- Newborn affected by premature rupture of membranesHealth Condition 2: null- preterm neonates less than 37 weeks and less than 2kilograms

• Registration Number: CTRI/2017/05/008533
• Lead Sponsor: Monica Rita Hendricks

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 117

Inclusion Criteria

1.Pre term Neonates who are less than 37 weeks of gestation

2.Pre term Neonates who weigh two kilograms and below, at the time of the study

3.Pre term Neonates who are stable enough for kangaroo mother care and nurture interventions, which include firm sustained touch, odor exchange and vocal soothing as determined by the treating physician.

Mothers:

Motherâ??s of pre term neonates who are physically and psychologically stable.

Physical stable means mothers who are not in the MICU and who are not confined to the bed for medical reasons and who are not able to visit their neonates because of medical conditions

The psychological stability is assessed using Edinburgh Postnatal Depression Scale.

Exclusion Criteria

Neonates:

1.The neonates who are residing outside the geographical boundaries of Bangalore.

2.The neonates who are enrolled in other RCTâ??s.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this study the primary outcome is the neurodevelopmental outcome. It refers to the extent to which, the nurture intervention has an impact on the neonate in terms of: <br/ ><br>Neurodevelopment outcomes, screening for autism and assesment of language development. <br/ ><br>All the outcomes would be assessed at 1 and a half years of corrected age of the neonate. <br/ ><br>All the outcomes would be assessed at 1 and a half years of corrected age of the neonate. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: In this study the primary outcome is the neurodevelopmental outcome. It refers to the extent to which, the nurture intervention has an impact on the neonate in terms of: <br/ ><br>Neurodevelopment outcomes, screening for autism and assesment of language development <br/ ><br>All the outcomes would be assessed at 1 and a half years of corrected age of the neonate. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
nilTimepoint: nil