Skip to main content
OpenTrials
Completed

NCT Number: NCT03574350

Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants

Kangaroo position (KP), the essential component of the Kangaroo Mother Care (KMC) method, has been increasingly implemented, given the benefits of early skin-to-skin contact on the cerebral maturation of preterm infants. In addition it allows for parents to bond with their infants and humanize the care of fragile infants in neonatal units. Evidence on kinesthetic stimulation (KS) is scarce and currently there is no available evidence on KS during the KP. KS is associated with massage in this paper

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Growth Acceleration Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

30 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nathalie Charpak

Bogotá, Cundinamarca, 110231, Colombia

About this study

The objective is to study the impact of standardized KS delivered either in KP (KSKP) or in an incubator (KSI) on the early growth of very preterm infants.

Patients and methods: Sixty six newborns ≤32 weeks of gestational age at birth received KS delivered 3 times/day during KP or in an incubator. They were randomized when the infants were considered eligibleto initiate KMC which was part of the routine care for all newborns in the Neonatal Care Unit (NCU). The primary outcome were the weight gain (g/kg/day) between randomization, 5, and 15 days after the start of the intervention and weight at 40 weeks of gestational age (term). The secondary outcomes were the same measures according to the chronological age (days of life) of the infant at randomization.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm infants (GA ≤33 weeks of gestation)
  • Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.

Exclusion criteria

  • Infants with congenital anomalies
  • Unstable during the first 15 days of life

Treatment and study plan

KS in Kangaroo Position

Behavioral

KSKP was applied daily at regular interval corresponding to the presence of parents. Our protocol is based on the Tiffany Field's protocol with some adjustments corresponding to the constraints of the hospital : the KS was applied 3 times a day and during 15 consecutive days in the hospital or at home and parents were responsible of delivering the intervention. Sunflower oil was used. During the first 5 days, parents performed KSKP with the support of the psychologist. After day 5, parents were expected to perform KSKP by themselves but could ask for help at any moment while in hospital or in the ambulatory follow-up. The KS always began approximately 60 minutes after the feed.

Other names: KSKP

KS in incubator

Behavioral

The infant is in the incubator, unclothed with diaper. Parents delivered KSI with the infant in supine position, stroking with the flats of the fingers with moderate pressure. Five 1-minute intervals, consisting of six 10-s periods of stroking, were applied to the following body regions: head, back, both legs and arms. The same process was repeated in prone position. The last part of the intervention was composed of 6 flexions of each extremity.

Other names: KSI

Primary outcomes

  1. Weight gain after randomization up to 5 days

    Time frame: Between randomization and 5 days post randomization

    weight gain (g/kg/day)

  2. Weight gain after randomization up to 15 days

    Time frame: Between randomization and 15 days post randomization

    weight gain (g/kg/day)

  3. Weight at 40 weeks of gestational age

    Time frame: at 40 weeks of gestational age

    Weight in grames

Secondary outcomes

  1. Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age

    Time frame: after randomization up to 5 days if randomization was made before 5 days of chronological age

    Weight gain(g/k/d)

  2. Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age

    Time frame: after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age

    Weight gain(g/k/d)

  3. Weight at 40 weeks if randomization was made before 5 days of chronological age

    Time frame: at 40 weeks of gestational age if randomization was made before 5 days of chronological age

    Weight in grames

  4. Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age

    Time frame: after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age

    Weight gain(g/k/d)

  5. Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age

    Time frame: after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age

    Weight gain(g/k/d)

  6. Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age

    Time frame: at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age

    Weight in grames

  7. Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age

    Time frame: after randomization up to 5 days if randomization was made more than 10 days of chronological age

    Weight gain(g/k/d)

  8. Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age

    Time frame: after randomization up to 15 days if randomization was made more than 10 days of chronological age

    Weight gain(g/k/d)

  9. Weight at 40 weeks if randomization was made more than 10 days of chronological age

    Time frame: at 40 weeks of gestational age if randomization was made more than 10 days of chronological age

    Weight in grames

Sponsors and collaborators

Lead sponsor

Nathalie Charpak

Other

Collaborators

  • Hospital Universitario San Ignacio
  • Laval University

Registry information

Official study title

Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants Either In Kangaroo Position or in Incubator: A Randomized Control Trial

Acronym: KISONKAP

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Jul 2, 2018
Registry last updated
Jul 2, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.