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OpenTrials
Completed

NCT Number: NCT03740594

Effect of KMC on Neurobehavior 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.

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Key information

Conditions

Neonatal Neurobehavior

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KMC

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.

Primary outcomes

  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 outcomes

  1. Salivary cortisol

    Time frame: 7 days

    measuring salivary cortisol

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 14, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.