Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding. The main question it aims to answer are: • Is there a difference in test weight and physiological parameters between the infants in whom the first oral feeding was performed by the mother and the infants in whom the first oral feeding was performed by the intensive care unit nurse with a bottle? Researchers will compare the breastfed group with the bottle-fed group to see if there are differences in test weight and physiological parameters.


Clinical Trial Description

In the pre-feeding stage of the research, the parents of the preterms included in the sample will be met and informed about the research. Written and verbal consent will be obtained from parents who agreed to participate in the study. "Preterm Infants Information Form" will be filled by the researcher before feeding and "Feeding Monitoring Form" will be filled during feeding. By randomization, it will be determined which of the experimental and control groups the preterm infant will be assigned to. It will be ensured that the interventions that will affect the vital signs of the preterms in both groups before feeding are not applied. Oxygen saturation and heart rate will be monitored for 30 minutes before, during and after feeding for all groups. Preterms in both groups will be dressed in clean and dry diapers by cleaning their bottoms before feeding, and will be weighed naked with a digital baby scale by removing their clothes. Weighing the preterms with an electronic precision balance before and after feeding - the test weighing - will be used to measure the amount of milk the preterm is expressing from the breast or bottle. The preterm will then be fed loosely wrapped in a cotton blanket. If the oxygen saturation level of all preterm infants falls below 90% during feeding, it will be considered desaturated and the feeding will be stopped. The preterm infants will continue to be fed when the oxygen saturation is ≥ 90% and the heart rate is 120-160/min. Feeding will be limited to a total of 30 minutes for infants in both groups, including rest intervals, and will not take longer. When the feeding is complete, preterms in both groups will be weighed naked without changing the diaper under the feeding process. It will be ensured that interventions that may affect the vital signs of all preterms included in the study are not applied when feeding is completed. The oxygen saturation and heart rate of the preterms in both groups will be monitored for 30 minutes after the feeding is completed. When feeding is complete, preterms in both groups will be placed on the same mother's breast in the right lateral position to facilitate gastric emptying. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05651035
Study type Interventional
Source Istanbul University - Cerrahpasa (IUC)
Contact Nagihan Sabaz, MSc
Phone +905319468677
Email nagihan.semin@gmail.com
Status Recruiting
Phase N/A
Start date April 20, 2020
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04487418 - Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Enrolling by invitation NCT02687685 - Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH) N/A
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT02913638 - A Post Breastfeeding Follow-Up Study N/A
Completed NCT03033459 - Prenatal Lactation-Focused Motivational Interviewing N/A
Not yet recruiting NCT05846828 - Cognitive Functions in Breastfed Preschool Children
Completed NCT05629403 - Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
Completed NCT05944471 - The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk N/A
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting NCT05560750 - Lingual Frenulum in Newborn Infants (LINNE) N/A
Completed NCT03232762 - Effects of Diet on Pregnancy Outcome and Child Obesity N/A
Recruiting NCT02186613 - Telephone Support From Primary Care for Breastfeeding Mothers N/A
Completed NCT01687634 - Home Visiting for Low Income, Pregnant Women N/A
Completed NCT01459991 - The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women N/A
Completed NCT03574766 - Meditation for NICU Moms N/A
Recruiting NCT03945474 - Osteopathic Manipulation in Breastfed Newborns N/A
Recruiting NCT06107933 - Developmental Impacts of Microplastics Exposure in Early Life
Not yet recruiting NCT05059574 - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies N/A
Completed NCT04578925 - Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents N/A