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

Nathalie Charpak

Status: Completed

Conditions: Preterm Infant; Growth Acceleration; Neurobehavioral Manifestations

Treatments: Behavioral: KS in Kangaroo Position; Behavioral: KS in incubator

Study type: Interventional

Funder types: Other

Identifiers

NCT03574350

KangarooF

xxxxx (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 30 to 33 weeks old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 2 patient groups

KS in Kangaroo Position (KSKP)

Experimental group

Description:

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

Treatment:

Behavioral: KS in Kangaroo Position

KS in incubator (KSI)

Active Comparator group

Description:

The infant is in the incubator, unclothed with diaper.

Treatment:

Behavioral: KS in incubator