Effect of KMC on Neurobehavior of Preterm Neonates

NCT ID: NCT03740594

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-02-01

Brief Summary

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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

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Conditions

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Neonatal Neurobehavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KMC 60 min group

Group Type ACTIVE_COMPARATOR

KMC

Intervention Type BEHAVIORAL

Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.

KMC 120 min group

Group Type ACTIVE_COMPARATOR

KMC

Intervention Type BEHAVIORAL

Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.

control group

Group Type ACTIVE_COMPARATOR

KMC

Intervention Type BEHAVIORAL

Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.

Interventions

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KMC

Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Mohamed Shinkar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Effect of KMC on neurobehavior

Identifier Type: -

Identifier Source: org_study_id

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