The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns

NCT05923437 | Unknown

• 1 other identifier: SelcukUnı42
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Feeding, Exclusive; Hospitalization; Feeding Patterns

Keywords

Breast milk; Nutrition; Nursing; Chronobiology; Circadian rhythm; Sleep wake cycle; Newborn

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Newborn Growth and Physiologic Parameters Follow-up Chart

  Second measurement - up the end of the second day night and day measurements

• Newborn Circadian Rhythm Follow-up Chart

  Second measurement - up the end of the second day circadian rhythm measurements

• Newborn Growth and Physiologic Parameters Follow-up Chart

  Third measurement - up the end of the third day night and day measurements

• Newborn Circadian Rhythm Follow-up Chart

  Third measurement - up the end of the third day circadian rhythm measurements

Study Arms (2)

Experimental: Interventions Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Feeding model group with a chronobiological approach 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).

Experimental: Interventions Group

Eligibility Criteria

• Age: 28 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
• th 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University

Konya, Turkey (Türkiye)

RECRUITING

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 35634367 RESULT

• 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.

  PMID: 34713833 RESULT

MeSH Terms

Conditions

Breast Feeding; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Sibel Kucukoglu

  Selcuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel Kucukoglu

CONTACT

+903322231623; s_nadaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: August 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)