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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Infant, Growth Acceleration, Neurobehavioral Manifestations

Intervention / Treatment
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* Behavioral: KS in Kangaroo Position
* Behavioral: KS in incubator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KS in Kangaroo Position (KSKP)<br>KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position. | Behavioral: KS in Kangaroo Position<br>* 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.<br>* Other names: KSKP;|
| Active Comparator: KS in incubator (KSI)<br>The infant is in the incubator, unclothed with diaper. | Behavioral: KS in incubator<br>* 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.<br>* Other names: KSI;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kangaroo position, Kinesthetic Stimulation, Kangaroo Mother Care, Bonding