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Effect of KMC on Neurobehavior of Preterm Neonates

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ClinicalTrials.gov Identifier: NCT03740594
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Mohamed Shinkar, 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.

Condition or disease Intervention/treatment Phase
Neonatal Neurobehavior Behavioral: KMC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : February 1, 2018

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Salivary cortisol [ Time Frame: 7 days ]
    measuring salivary cortisol



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Dina Mohamed Mohamed Shinkar, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03740594     History of Changes
Other Study ID Numbers: Effect of KMC on neurobehavior
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No