The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns

Effect of Chronobıologıcal Approach Feedıng Model on Cırcadıan Rhythm, Growth and Physıologıcal Parameters in Newborn: A Randomızed Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Hospitalization; Feeding Patterns; Breast Feeding, Exclusive
• Intervention / Treatment: Other: Feeding model group with a chronobiological approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sibel Kucukoglu; Phone Number: +903322231623; Email: s_nadaroglu@hotmail.com

Study Locations

• Turkey
  • Kirsehir, Turkey
    • Recruiting
    • Kirsehir Ahi Evran University
    • Contact: Edanur Tar; Phone Number: +903862804732; Email: edanurtar.1107@gmail.com
  • Konya, Turkey
    • Recruiting
    • Selcuk University
    • Contact: Murat Konak; Email: drmkonak@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn Introductory Information Form	The form prepared by the researcher in line with the literature (Galland et al., 2012; Huang et al., 2021; Caba-Flores et al., 2022) consists of questions including the obstetric characteristics of the infant such as gender, gestational-postnatal age, type of delivery, APGAR scores, birth weight, height, head circumference, and the current clinical status of the infant such as diet, comorbidity, and total number of hospitalization days. The questionnaire form was sent to 5 academicians specialized in Pediatric Nursing, their expert opinions were obtained, and the questionnaire form was finalized by making the necessary changes in line with their suggestions. Information about the newborns in the control and experimental groups was collected by the researcher through the "Newborn Introductory Information Form" before the study, hospital records of the newborn and the primary nurse through face-to-face interview method will be collected in about 5 minutes.	First measurement - Before the study (before randomization)
Newborn Growth and Physiologic Parameters Follow-up Chart	"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.	First measurement - up the end of the first day night and day measurements
Newborn Circadian Rhythm Follow-up Chart	At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.	First measurement -up the end of the first day circadian rhythm measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn Growth and Physiologic Parameters Follow-up Chart	"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.	Second measurement - up the end of the second day night and day measurements
Newborn Circadian Rhythm Follow-up Chart	At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.	Second measurement - up the end of the second day circadian rhythm measurements
Newborn Growth and Physiologic Parameters Follow-up Chart	"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.	Third measurement - up the end of the third day night and day measurements
Newborn Circadian Rhythm Follow-up Chart	At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.	Third measurement - up the end of the third day circadian rhythm measurements

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Sibel Kucukoglu, Selcuk University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Nutrition; Nursing; Newborn; Circadian rhythm; Breast milk; Chronobiology; Sleep wake cycle
• Other Study ID Numbers: SelcukUnı42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be shared after the article is published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No