Ireland
--:--IST
Recruiting Not applicable

Effect of Kangaroo Care on Test Weighing

NCT04252547 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-06-09
Last updated
2025-05-02

Condition(s) studied

Kangaroo CareWeight GainOxygen SaturationHeart Rate

Investigational drug(s) / intervention(s)

Kangaroo CareControl

Kangaroo Care: The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. A chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. The infant's heart rate and oxygen saturation will also continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weight is measured without a diaper change and his/her weight will be recorded. Then he/she will be taken back in the incubator to sleep.

Control: The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before feeding when they are included in the study and then they will be breastfed by their mothers. The chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. Also, the infant's heart rate and oxygen saturation will continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weighed without a diaper change and his/her weight will be recorded. When the care process is over, it will be taken back in the incubator to sleep.

Study summary

The study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.

Eligibility

Sex
ALL
Min age
32 Weeks
Max age
40 Weeks
Healthy volunteers
Accepted
Inclusion Criteria: \- Agreeing to participate in the study for parents. The inclusion criteria for infants were as follows; * Attaining to oral feeding by the physician in the neonatal intensive care unit * Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle * Being at 32-39+6 postmenstrual week during the time they are included in the study * Having body weight of 1500 grams and above * Being breastfed at least once * Having no health problems other than being preterm Exclusion Criteria: The exclusion criteria for infants were as follows; * Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases * Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.) * Receiving oxygen support

Primary outcome measure(s)

  • Test Weighing — Change the body weight before feeding to after feeding at 1 day
    The infants' body weight before and after feeding will be measured using an 'Infant Scale'. The infants will be weighed naked only in their diaper before and after feeding, in order to evaluate the amount of milk they have received from their mothers' breast.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medipol University Istanbul Istanbul Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04252547 on ClinicalTrials.gov ↗ ← All trials in Turkey