Effect of KMC on Neurobehavior of Preterm Neonates

November 13, 2018 updated by: Dina Mohamed Mohamed Shinkar, Ain Shams University

Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: control group
Behavioral: 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.
ACTIVE_COMPARATOR: KMC 60 min group
Behavioral: 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.
ACTIVE_COMPARATOR: KMC 120 min group
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Time Frame: 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.
the age of 36 weeks
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Time Frame: 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.
the age of 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol
Time Frame: 7 days
measuring salivary cortisol
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

November 10, 2018

First Submitted That Met QC Criteria

November 10, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Effect of KMC on neurobehavior

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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