Effect of Kangaroo Care on Test Weighing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-40
SponsorIstanbul University - Cerrahpasa
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Kangaroo Care
Other interventionThe 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 interventionThe 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Grup 1Experimental treatment 2 interventions
Group B: Grup 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Test Weighing
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.
Time frame
Change the body weight before feeding to after feeding at 1 daySecondary outcomes
1
Heart Rate
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.
Time frame
Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding2
Oxygen Saturation
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.
Time frame
Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feedingSponsors and contacts
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Source ClinicalTrials.gov