Weight Gain Clinical Trial
Official title:
The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants
Verified date | October 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 46 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 32 Weeks to 40 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change the body weight before feeding to after feeding at 1 day | |
Secondary | 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. | Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding | |
Secondary | 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. | Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT05508750 -
Growth and Safety Clinical Trial on a New Infant Formula
|
N/A | |
Not yet recruiting |
NCT03225456 -
Oxytocin and Eating
|
Phase 2 | |
Completed |
NCT02227043 -
Study Of Weight Development Over Time
|
N/A | |
Not yet recruiting |
NCT01916603 -
Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development
|
N/A | |
Completed |
NCT01958307 -
Healthy Living in Pregnancy
|
N/A | |
Completed |
NCT01693666 -
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
|
N/A | |
Completed |
NCT01461824 -
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
|
Phase 3 | |
Terminated |
NCT00759993 -
Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
|
Phase 2 | |
Completed |
NCT00634530 -
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
|
N/A | |
Completed |
NCT00995462 -
Prevention of Weight Gain in University Students
|
N/A | |
Completed |
NCT00122213 -
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
|
Phase 2 | |
Completed |
NCT00306449 -
Prevention of Weight Gain in Young Adults
|
N/A | |
Completed |
NCT03996551 -
ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study
|
N/A | |
Recruiting |
NCT03675464 -
Study of Human Adipose Tissue (LOSHAT)
|
||
Completed |
NCT04282655 -
Effect of Milk Warming on the Very Low Birth Weight Infant
|
N/A | |
Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
Completed |
NCT04069351 -
Body Composition Changes During Overfeeding Plus Resistance Training
|
N/A | |
Completed |
NCT00687115 -
Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting
|
Phase 2 |