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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03574350
Acronym
KISONKAP
Enrollment
66
Registered
2018-07-02
Start date
2013-08-15
Completion date
2018-02-28
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Acceleration, Neurobehavioral Manifestations, Preterm Infant

Keywords

Kangaroo position, Kinesthetic Stimulation, Kangaroo Mother Care, Bonding

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.

Interventions

BEHAVIORALKS 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.

BEHAVIORALKS 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.

Sponsors

Laval University
CollaboratorOTHER
Hospital Universitario San Ignacio
CollaboratorOTHER
Nathalie Charpak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes 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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
30 Weeks to 33 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight gain after randomization up to 5 daysBetween randomization and 5 days post randomizationweight gain (g/kg/day)
Weight gain after randomization up to 15 daysBetween randomization and 15 days post randomizationweight gain (g/kg/day)
Weight at 40 weeks of gestational ageat 40 weeks of gestational ageWeight in grames

Secondary

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

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026