Clinical trial NCT05923437: The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns
Official title: Effect of Chronobıologıcal Approach Feedıng Model on Cırcadıan Rhythm, Growth and Physıologıcal Parameters in Newborn: A Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Feeding, Exclusive
Hospitalization
Feeding Patterns
Keywords: Breast milk
Nutrition
Nursing
Chronobiology
Circadian rhythm
Sleep wake cycle
Newborn
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted with a total of 40 newborns (intervention group=20, control group= 20). In order to prevent selection bias in the study, participants will be randomly assigned to the intervention and control groups and the "block randomization" method, one of the "fixed probability randomization" methods, will be used in randomization. Each of the intervention and control groups will be represented by one of the letters A and B. In the creation of the 4-block (2A, 2B); the assignment of 10 blocks from the total number of options determined using the "permutation" method will be carried out with the random numbers table tool on the www.random.org website.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.

Detailed description: The newborn period is a period when all babies need their basic needs to be met and all babies are very sensitive physiologically, neuro-biologically and psycho-emotionally, but the newborn period is also a very important period in the development of circadian rhythm. It is important to establish a healthy sleep pattern for the formation of the circadian rhythm and the continuation of the functions of all other systems, especially the central nervous system. Formation of circadian rhythm in newborns; It shows a better development in the first 3 months with the effect of environmental factors such as nutrition, light, mother-baby interaction. Breast milk is a nutrient for the growth and development of babies, in addition, breast milk plays an active role in the formation of the baby's circadian rhythm by transmitting information about the time of day to the babies through components such as hormones and immune elements. In cases where breastfeeding is not possible, it is thought that the delivery of expressed breast milk to the babies simultaneously with the "feeding model with a chronobiological approach" has important effects on the sleep-wake cycle and growth and development. In studies examining circadian rhythm in newborns in the world and in our country, the limited number of studies evaluating the relationship between circadian rhythm and breast milk draws attention and further studies are recommended. However, there is no published study evaluating the effect of simultaneous administration of breast milk to the infant in line with the "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.

Eligibility criteria: Inclusion Criteria:

* Gestational age between 28-42 weeks
* Birth weight between 1500 and 4200 gr
* Hospitalization for at least 3 days
* Exclusive breastfeeding (oral/ enteral)
* Feeding at 3-hour intervals
* Stable health condition
* Spontaneous breathing

Exclusion Criteria:

* Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
* 5th minute apgar score below 4 at the time of delivery
* Resuscitation requirement
* Having a congenital anomaly
* Interventional intervention in the head region
* Central nervous system dysfunction
* Postpartum medical complications

Primary outcomes:
measure: Newborn Introductory Information Form
timeFrame: First measurement - Before the study (before randomization)
measure: Newborn Growth and Physiologic Parameters Follow-up Chart
timeFrame: First measurement - up the end of the first day night and day measurements
measure: Newborn Circadian Rhythm Follow-up Chart
timeFrame: First measurement -up the end of the first day circadian rhythm measurements
Secondary outcomes:
measure: Newborn Growth and Physiologic Parameters Follow-up Chart
timeFrame: Second measurement - up the end of the second day night and day measurements
measure: Newborn Circadian Rhythm Follow-up Chart
timeFrame: Second measurement - up the end of the second day circadian rhythm measurements
measure: Newborn Growth and Physiologic Parameters Follow-up Chart
timeFrame: Third measurement - up the end of the third day night and day measurements
measure: Newborn Circadian Rhythm Follow-up Chart
timeFrame: Third measurement - up the end of the third day circadian rhythm measurements
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
citation: Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.