Skip to content

Effect of Kangaroo Care on Test Weighing

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252547
Enrollment
46
Registered
2020-02-05
Start date
2024-06-09
Completion date
2026-01-09
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate, Kangaroo Care, Oxygen Saturation, Weight Gain

Keywords

kangaroo care, test weighing, Heart rate, oxygen saturation, preterm infants

Brief 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.

Detailed description

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.

Interventions

OTHERKangaroo 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.

OTHERControl

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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 40 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Test WeighingChange the body weight before feeding to after feeding at 1 dayThe 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

MeasureTime frameDescription
Heart RateChange the Heart Rate 10 minutes before feeding to 2 minutes after feedingA 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.
Oxygen SaturationChange the Oxygen Saturation 10 minutes before feeding to 2 minutes after feedingA 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactCanan Genç, BSN
cananuzun5561@gmail.com(0216) 910 19 07
Backup ContactDuygu Gözen, Assoc. Prof.
dgozen@istanbul.edu.tr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026