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NCT Number: NCT04252547

Effect of Kangaroo Care on Test Weighing

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.

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Key information

Age range

32 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Test weighing is a feeding evaluation method which is used for evaluating the increase in infant's body weight and the amount of food intake before and after breastfeeding. Each gram is evaluated to be equivalent to one cc breast milk. The aim of the study is to evaluate the effect of kangaroo care applied to the preterm infants that have attained oral feeding and are breastfed by their mothers, on their physiological parameters, feeding condition and body weight increase. After weighing the infant only in his/her diaper before the feeding and applying kangaroo care in which skin-to-skin contact will be provided for half an hour, the mother will breastfeed the infant. The infant will be weighed once again after the feeding without diaper change and the effect of kangaroo care on test weighing and physiological parameters during the feeding process will be evaluated. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 23 for each group and 46 in total. Parents of the infants meeting the study inclusion criteria will be informed both in written and verbally and then the study will be conducted with mothers who agree to participate in the study with their infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kangaroo Care

Other

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

Other

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.

Primary outcomes

  1. Test Weighing

    Time frame: 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.

Secondary outcomes

  1. Heart Rate

    Time frame: Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding

    A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Heart rate of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.

  2. Oxygen Saturation

    Time frame: Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding

    A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Oxygen Saturation of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Canan Genç, BSN

CONTACT

[email protected]

(0216) 910 19 07

Duygu Gözen, Assoc. Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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