Actively Recruiting

Phase Not Applicable
Age: 32Weeks - 40Weeks
All Genders
Healthy Volunteers
ID04252547

The Effect of Kangaroo Mother Care on Test Weighing in Preterm Infants

Led by Istanbul University - Cerrahpasa · Updated on 2025-05-02

46

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of kangaroo care on preterm infants who have started oral feeding in the neonatal intensive care unit. The study aims to understand how skin-to-skin contact during feeding influences physiological parameters, feeding behavior, and weight gain. This is a randomized controlled trial involving infants born between 26 and 36+6 gestational weeks and currently at 32 to 39+6 postmenstrual weeks. The study divides infants into two groups using a crossover design. Group 1 receives kangaroo care during the first feeding hour, followed by breastfeeding, while Group 2 is breastfed first and then receives kangaroo care during the second feeding hour. Kangaroo care involves holding infants skin-to-skin on their mothers' chests for 30 minutes, with continuous recording of heart rate and oxygen saturation. Infants are weighed before and after feeding without diaper changes to assess food intake. Participants will undergo measurements of weight, heart rate, and oxygen saturation before, during, and after feeding. Researchers will record the timing of sucking during breastfeeding and monitor physiological changes. The main outcome is the change in body weight from before to after feeding. Secondary outcomes include changes in heart rate and oxygen saturation. The study length varies per participant, with detailed monitoring during feeding sessions and rest periods afterward.

CONDITIONS

Brief Title

Effect of Kangaroo Care on Test Weighing

Who Can Participate

Age: 32Weeks - 40Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents agree to participate in the study
  • Infants have started oral feeding as confirmed by a physician in the neonatal intensive care unit
  • Infants were born at 26 to 36+6 gestational weeks
  • Infants are between 32 and 39+6 postmenstrual weeks at study entry
  • Infants weigh 1500 grams or more
  • Infants are breastfed at least once
  • Infants have no health problems other than prematurity
Not Eligible

You will not qualify if you...

  • Infants with gastrointestinal, neurological, or genetic diseases such as necrotizing enterocolitis, intracranial bleeding, hydrocephaly, omphalocele, Down syndrome, or gastroschisis
  • Infants with conditions preventing oral feeding, including cleft palate, cleft lip, facial muscle paralysis, or craniofacial abnormalities
  • Infants receiving oxygen support

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Two feeding sessions on separate days

Participants will undergo two feeding sessions involving kangaroo care and breastfeeding to evaluate the effect on physiological parameters and body weight. In one session, infants receive 30 minutes of skin-to-skin kangaroo care before breastfeeding. In the other session, infants are breastfed without prior kangaroo care. Heart rate, oxygen saturation, and weight are measured before, during, and after feedings.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

Istanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

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Research Team

C

Canan Genç, BSN

D

Duygu Gözen, Assoc. Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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