MedDataX Logo

The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns

NCT ID: NCT05923437

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Feeding, Exclusive Hospitalization Feeding Patterns

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast milk Nutrition Nursing Chronobiology Circadian rhythm Sleep wake cycle Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Interventions Group

Breast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiological approach", simultaneously with the mother's supply.

Group Type EXPERIMENTAL

Feeding model group with a chronobiological approach

Intervention Type OTHER

Breast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiologic approach" simultaneously with the provision from the mother, and the newborn will be ensured to receive breast milk in accordance with the day cycle. Within the scope of the study, firstly, mothers and nurses in the NICU will be informed about the study. Mothers will be asked to put the milk mothers express between 06:00-17:59 in the "daytime breast milk storage bag" and the milk mothers express between 18:00-05:59 in the "nighttime breast milk storage bag" and bring them to the unit. The brought breast milk will be prepared by the nurses by matching "day and night" milk according to the dates, with the first milk brought in priority, and the newborns will be fed by using the "time of day factor" (cycle so that the milk collected during the day will be given during the day and the milk expressed at night will be given at night).

Control Group

Breast milk will be given to newborns in the control group according to the clinical routine and infants will be followed up for 3 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Feeding model group with a chronobiological approach

Breast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiologic approach" simultaneously with the provision from the mother, and the newborn will be ensured to receive breast milk in accordance with the day cycle. Within the scope of the study, firstly, mothers and nurses in the NICU will be informed about the study. Mothers will be asked to put the milk mothers express between 06:00-17:59 in the "daytime breast milk storage bag" and the milk mothers express between 18:00-05:59 in the "nighttime breast milk storage bag" and bring them to the unit. The brought breast milk will be prepared by the nurses by matching "day and night" milk according to the dates, with the first milk brought in priority, and the newborns will be fed by using the "time of day factor" (cycle so that the milk collected during the day will be given during the day and the milk expressed at night will be given at night).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Selcuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sibel Küçükoğlu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sibel Kucukoglu

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Selcuk University

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Kirsehir Ahi Evran University

Kırşehir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sibel Kucukoglu

Role: CONTACT

Phone: +903322231623

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Murat Konak

Role: primary

Edanur Tar

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 35634367 (View on PubMed)

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.

Reference Type RESULT
PMID: 34713833 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SelcukUnı42

Identifier Type: -

Identifier Source: org_study_id