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

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

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

Study Overview

• Status: Completed
• Conditions: Neurobehavioral Manifestations; Growth Acceleration; Preterm Infant
• Intervention / Treatment: Behavioral: KS in Kangaroo Position; Behavioral: KS in incubator

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 110231
      • Nathalie Charpak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: KS in Kangaroo Position (KSKP); KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.	Behavioral: KS in Kangaroo Position; 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
ACTIVE_COMPARATOR: KS in incubator (KSI); The infant is in the incubator, unclothed with diaper.	Behavioral: KS in incubator; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain after randomization up to 5 days	weight gain (g/kg/day)	Between randomization and 5 days post randomization
Weight gain after randomization up to 15 days	weight gain (g/kg/day)	Between randomization and 15 days post randomization
Weight at 40 weeks of gestational age	Weight in grames	at 40 weeks of gestational age

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nathalie Charpak
• Collaborators: Hospital Universitario San Ignacio; Laval University
• Investigators: Principal Investigator: Andrea C Aldana Acosta, PhD, Universidad Piloto de Colombia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Kinesthetic stimulation in Kangaroo Position (KSKP)

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2013
• Primary Completion (ACTUAL): August 30, 2016
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): July 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Bonding; Kangaroo Mother Care; Kangaroo position; Kinesthetic Stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Neurobehavioral Manifestations
• Other Study ID Numbers: KangarooF; XXXXX (Université Laval)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No