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Effect of KMC on Neurobehavior of Preterm Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 10, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE August 1, 2016
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2018)
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) [ Time Frame: the age of 36 weeks ]
applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2018)
Salivary cortisol [ Time Frame: 7 days ]
measuring salivary cortisol
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of KMC on Neurobehavior of Preterm Neonates
Official Title  ICMJE Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Neonatal Neurobehavior
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: KMC 60 min group
    Intervention: Behavioral: KMC
  • Active Comparator: KMC 120 min group
    Intervention: Behavioral: KMC
  • Active Comparator: control group
    Intervention: Behavioral: KMC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2018)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2018
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740594
Other Study ID Numbers  ICMJE Effect of KMC on neurobehavior
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dina Mohamed Mohamed Shinkar, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP