Effect of KMC on Neurobehavior of Preterm Neonates

Not Applicable

Completed

• Conditions: Neonatal Neurobehavior
• Interventions: Behavioral: KMC

• Registration Number: NCT03740594
• Lead Sponsor: Ain Shams University

Brief Summary

This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2017-12-01
• Study Completion: 2018-02-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-11-10
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Stable preterm neonates with gestational age between 31 and 35 weeks.

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Exclusion Criteria

• Neonates with major congenital birth defects or chromosomal anomalies.
• Perinatal asphyxia and intra-ventricular hemorrhage.
• Hemodynamically significant cardiac abnormalities.
• Neonates received postnatal steroids.
• Neonates whose mothers had a history of drug abuse during pregnancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KMC 120 min group	KMC	-
KMC 60 min group	KMC	-
control group	KMC	-

Primary Outcome Measures

Name	Time	Method
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)	the age of 36 weeks	applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9. For stress, lethargy, non-optimal response and asymmetic reflexes, the higher the seb-scale, the worse. In other sub-scales, the higher the scale, the better.

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol	7 days	measuring salivary cortisol