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

Primary Purpose

Preterm Infant, Growth Acceleration, Neurobehavioral Manifestations

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
KS in Kangaroo Position
KS in incubator
Sponsored by
Nathalie Charpak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant focused on measuring Kangaroo position, Kinesthetic Stimulation, Kangaroo Mother Care, Bonding

Eligibility Criteria

30 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nathalie Charpak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KS in Kangaroo Position (KSKP)

KS in incubator (KSI)

Arm Description

KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.

The infant is in the incubator, unclothed with diaper.

Outcomes

Primary Outcome Measures

Weight gain after randomization up to 5 days
weight gain (g/kg/day)
Weight gain after randomization up to 15 days
weight gain (g/kg/day)
Weight at 40 weeks of gestational age
Weight in grames

Secondary Outcome Measures

Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age
Weight gain(g/k/d)
Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age
Weight gain(g/k/d)
Weight at 40 weeks if randomization was made before 5 days of chronological age
Weight in grames
Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age
Weight gain(g/k/d)
Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
Weight gain(g/k/d)
Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age
Weight in grames
Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age
Weight gain(g/k/d)
Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age
Weight gain(g/k/d)
Weight at 40 weeks if randomization was made more than 10 days of chronological age
Weight in grames

Full Information

First Posted
June 4, 2018
Last Updated
June 19, 2018
Sponsor
Nathalie Charpak
Collaborators
Laval University, Hospital Universitario San Ignacio
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1. Study Identification

Unique Protocol Identification Number
NCT03574350
Brief Title
Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants
Acronym
KISONKAP
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2013 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nathalie Charpak
Collaborators
Laval University, Hospital Universitario San Ignacio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Growth Acceleration, Neurobehavioral Manifestations
Keywords
Kangaroo position, Kinesthetic Stimulation, Kangaroo Mother Care, Bonding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two interventions groups of 33 each, participated in the study. The first group received Kinesthetic Stimulation in Kangaroo Position (KSKP) and the second group received Kinesthetic Stimulation In incubator (KSI ), both of the interventions were delivered by parents during the period of hospitalization and at home when the infant was discharged from Hospital until 40 weeks of gestational age.
Masking
InvestigatorOutcomes Assessor
Masking Description
The nurses who did anthropometrics measures didn't know the interventions assigned to each participant of the study, because the night shift was in charge of taking the data at 7:00 am in the mornings and the interventions were delivered in the morning shifts from 8:00 am until 5:00 pm. No interventions were delivered in the night.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KS in Kangaroo Position (KSKP)
Arm Type
Experimental
Arm Description
KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.
Arm Title
KS in incubator (KSI)
Arm Type
Active Comparator
Arm Description
The infant is in the incubator, unclothed with diaper.
Intervention Type
Behavioral
Intervention Name(s)
KS in Kangaroo Position
Other Intervention Name(s)
KSKP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
KS in incubator
Other Intervention Name(s)
KSI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight gain after randomization up to 5 days
Description
weight gain (g/kg/day)
Time Frame
Between randomization and 5 days post randomization
Title
Weight gain after randomization up to 15 days
Description
weight gain (g/kg/day)
Time Frame
Between randomization and 15 days post randomization
Title
Weight at 40 weeks of gestational age
Description
Weight in grames
Time Frame
at 40 weeks of gestational age
Secondary Outcome Measure Information:
Title
Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age
Description
Weight gain(g/k/d)
Time Frame
after randomization up to 5 days if randomization was made before 5 days of chronological age
Title
Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age
Description
Weight gain(g/k/d)
Time Frame
after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age
Title
Weight at 40 weeks if randomization was made before 5 days of chronological age
Description
Weight in grames
Time Frame
at 40 weeks of gestational age if randomization was made before 5 days of chronological age
Title
Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age
Description
Weight gain(g/k/d)
Time Frame
after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age
Title
Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
Description
Weight gain(g/k/d)
Time Frame
after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
Title
Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age
Description
Weight in grames
Time Frame
at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age
Title
Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age
Description
Weight gain(g/k/d)
Time Frame
after randomization up to 5 days if randomization was made more than 10 days of chronological age
Title
Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age
Description
Weight gain(g/k/d)
Time Frame
after randomization up to 15 days if randomization was made more than 10 days of chronological age
Title
Weight at 40 weeks if randomization was made more than 10 days of chronological age
Description
Weight in grames
Time Frame
at 40 weeks of gestational age if randomization was made more than 10 days of chronological age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea C Aldana Acosta, PhD
Organizational Affiliation
Universidad Piloto de Colombia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nathalie Charpak
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
110231
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21570125
Citation
Field T, Diego M, Hernandez-Reif M. Potential underlying mechanisms for greater weight gain in massaged preterm infants. Infant Behav Dev. 2011 Jun;34(3):383-9. doi: 10.1016/j.infbeh.2010.12.001. Epub 2011 May 13.
Results Reference
result
PubMed Identifier
16027695
Citation
Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
Results Reference
result
PubMed Identifier
19420271
Citation
Guzzetta A, Baldini S, Bancale A, Baroncelli L, Ciucci F, Ghirri P, Putignano E, Sale A, Viegi A, Berardi N, Boldrini A, Cioni G, Maffei L. Massage accelerates brain development and the maturation of visual function. J Neurosci. 2009 May 6;29(18):6042-51. doi: 10.1523/JNEUROSCI.5548-08.2009.
Results Reference
result
Links:
URL
https://www.youtube.com/watch?v=WrxDLOBiiZs
Description
Kinesthetic stimulation in Kangaroo Position (KSKP)

Learn more about this trial

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

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