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Effect of Kangaroo Care on Test Weighing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252547
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Canan Uzun, Istanbul University-Cerrahpasa

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.

Condition or disease Intervention/treatment Phase
Kangaroo Care Weight Gain Oxygen Saturation Heart Rate Other: Kangaroo Care Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Grup 1

-"During the Procedure" Group 1 The preprocedural measurements(weight, heart rate and oxygen saturation ) will be applied to the infants in Group 1 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.

During the second feeding hour, his/her heart rate and oxygen saturation will begin to be recorded ten minutes before the feeding hour. The data will be recorded for ten minutes and then the infant will be taken out of the incubator and weight is measured only in his/her clean diaper. He/she will be handed over to the mother to breastfeed.

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 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.

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 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.

Experimental: Grup 2

- "During the Procedure" Group 2 The preprocedural measurements will be applied to the infants in Group 2 before the first feeding hour when they are included in the study and then they will be breastfed by their mothers.

The preprocedural measurements (weight, heart rate and oxygen saturation) will be applied to the infant during the second feeding hour and then he/she will be held on his/her 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.

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 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.

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 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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252547


Contacts
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Contact: Canan Uzun, BSN 05372828808 cananuzun5561@gmail.com
Contact: Duygu Gözen, Assoc. Prof. dgozen@istanbul.edu.tr

Locations
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Turkey
Istanbul Medipol University Recruiting
Istanbul, Turkey
Contact: Canan Uzun, BSN    05372828808    cananuzun5561@gmail.com   
Contact: Duygu Gözen, Assoc. Prof.       dgozen@istanbul.edu.tr   
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Duygu Gözen, Assoc. Prof. Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing
Principal Investigator: Ayhan Taştekin, prof. Istanbul Medipol University, Pediatrics
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Responsible Party: Canan Uzun, RN, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04252547    
Other Study ID Numbers: 10840098-604.01.01-E.53511
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canan Uzun, Istanbul University-Cerrahpasa:
kangaroo care
test weighing
Heart rate
oxygen saturation
preterm infants
Additional relevant MeSH terms:
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Weight Gain
Body Weight
Body Weight Changes
Signs and Symptoms