Effect of Kangaroo Care on Test Weighing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kangaroo Care, Control.
- Who it may be relevant to
- Registry conditions: Kangaroo Care, Weight Gain, Oxygen Saturation, Heart Rate. Basic parameters: 32 Weeks — 40 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants
Overview
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
- Other 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 - Other 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 mot
Primary outcome measures
- Test Weighing [Time frame: Change the body weight before feeding to after feeding at 1 day]
Secondary outcome measures (2)
- Heart Rate [Time frame: Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding]
- Oxygen Saturation [Time frame: Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Medipol University — Istanbul
Identifiers
NCT: NCT04252547 · 10840098-604.01.01-E.53511