Effect of Cırcadıan Feedıng on Growth Parameters of Preterm Newborn

NCT06857149 | Active Not Recruiting

• 1 other identifier: Circadian Feeding
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as a randomized controlled experimental study to determine the effect of circadian feeding on the growth parameters of preterm newborns. The data of the study were collected from patients aged 32-34 in the Neonatal Intensive Care Unit (NICU) of Selçuk University Faculty of Medicine. It will consist of premature babies and mothers born during the first week of gestation. The sample size was planned to include 48 preterm newborns and their mothers. Mother-Preterm Introductory Information Form, Breast Milk Feeding Follow-up Form, Breast Milk Content Parameters Follow-up Form, Newborn Baby Follow-up Form, Baby scale and height meter will be used in data collection. Data will be used with SPSS 21.0 package program and Kolmogorov-Smirnov (K-S) test for normality. Chi square, independent sample t-test, paired simple t-test, Wilcoxon tests and analysis of variance in repeated measurements will be used in the analysis of the data. The research was conducted in the following order. All permissions were obtained for data collection. Individual characteristics were obtained from family members and recorded in the questionnaire. Newborns in the study or control group were randomly determined according to the day of admission. For the newborns in the study group, the milk expressed by the mother at night will be given to the baby at night, and the milk expressed during the day will be given to the baby for daytime feeding. During this one-month period, the baby's weight and height will be measured and recorded twice a week. For the newborns in the control group, the condition of "expressed milk is given first", which is used in routine practice, will be fulfilled, regardless of the day and night characteristics of the expressed breast milk. During this one-month period, the baby's weight and height will be measured and recorded twice a week. Measurements of all newborns were made at the same time of the day.

Conditions

Milk Expression, Breast; Nutrition

Keywords

Circadian feeding; Growth; Human milk; newborn

Outcome Measures

Primary Outcomes (2)

• height length

  the height length of the newborn will be measured (height in centimeters)

  Once a week for 4 weeks

• weight

  weight of the newborn will be measured (weight in kilograms).

  Once a week for 4 weeks

Study Arms (2)

Experimental:Circadian Rhythm Group

EXPERIMENTAL

In accordance with the physiology of breastfeeding, mothers will be asked to milk and deliver their milk to the ICU once every 3 hours. The mother will be asked to completely empty her breast with a milking machine. Before milking, the mother will wash her hands, and the parts of the milking machine that come into contact with the milk will also be boiled and disinfected after it is provided to be used. The mother will put the milk she has milked into a milking bag and deliver it to the researcher by writing the date and time on it. Feeding will be initiated by the neonatal specialist with the determination that the newborn is stable. During the period when mothers' babies are in the neonatal intensive care unit, the feeding of the babies in the circadian rhythm group will be carried out taking into account the date and day/night practice. The milk that the mother expresses at night will be given to her baby at night, and the milk that she expresses during the day will be used for day

Other: Human milk

Experimental:Control Group

ACTIVE COMPARATOR

The application in the control group is similar to the application in the cycadian rhythm group (mother's milking technique, collection method, storage and appropriate transportation, etc.) instead of the "milk expressed first is given first" condition used in routine practice, without taking into account the day and night characteristics of the expressed breast milk. will be brought. The routine practice of the clinic will continue. In line with the practice of the Turkish Neonatology Association (2018) and the clinic, the information of babies given breast milk fortifiers in the expressed breast milk of enterally fed babies will be recorded. In order to ensure that the data is collected safely and to facilitate monitoring, it will be recorded in the "Breastfeeding Follow-up Form", as in every feeding intervention group. The monitoring of babies is the same as in the circadian rhythm group. For the first month, the baby's weight and height will be measured and recorded twice a week.

Other: Control Group

Interventions

Human milk OTHER

In accordance with the physiology of breastfeeding, mothers will be asked to milk and deliver their milk to the ICU once every 3 hours. The mother will be asked to completely empty her breast with a milking machine. Before milking, the mother will wash her hands, and the parts of the milking machine that come into contact with the milk will also be boiled and disinfected after it is provided to be used. The mother will put the milk she has milked into a milking bag and deliver it to the researcher by writing the date and time on it. Feeding will be initiated by the neonatal specialist with the determination that the newborn is stable. During the period when mothers' babies are in the neonatal intensive care unit, the feeding of the babies in the circadian rhythm group will be carried out taking into account the date and day/night practice. The milk that the mother expresses at night will be given to her baby at night, and the milk that she expresses during the day will be used for dayt

Experimental:Circadian Rhythm Group

Control Group OTHER

The application in the control group is similar to the application in the cycadian rhythm group (mother's milking technique, collection method, storage and appropriate transportation, etc.) instead of the "milk expressed first is given first" condition used in routine practice, without taking into account the day and night characteristics of the expressed breast milk. will be brought. The routine practice of the clinic will continue. In line with the practice of the Turkish Neonatology Association (2018) and the clinic, the information of babies given breast milk fortifiers in the expressed breast milk of enterally fed babies will be recorded. In order to ensure that the data is collected safely and to facilitate monitoring, it will be recorded in the "Breastfeeding Follow-up Form", as in every feeding intervention group. The monitoring of babies is the same as in the circadian rhythm group. For the first month, the baby's weight and height will be measured and recorded twice a week.

Experimental:Control Group

Eligibility Criteria

• Age: 32 Weeks - 34 Weeks
• Gender Eligibility Details: preterm newborns
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The mother is healthy (without a history of preeclampsia, hypertension, diabetes, hepatitis B or C, HIV, tuberculosis, mastitis or oncological disease)
• The mother's age is 32-34. Having given birth between weeks of gestation and staying in a hospital hotel
• The postnatal age of the newborn is 7 days or more
• Babies fed by gavage and oral methods \*In order for the preterm baby to be fed effectively and safely orally, it is necessary for the preterm baby to be able to coordinate sucking-swallowing as well as breathing (Tian et al. 2015). Gavage feeding is a priority in babies who achieve this coordination (TND, 2018). In babies who are able to coordinate sucking, swallowing and breathing, oral feeding will be started after an assessment of readiness for oral feeding will be made.
• The mother does not follow a special diet
• Mother is not a vegetarian
• Mother's non-smoking
• The mother must have a body mass index within normal limits (BMI = 18.50-24.99) (WHO, 2022b)
• The baby is lying in the neonatal intensive care unit,
• The mother's inability to breastfeed her baby and feeding her own milk by regularly milking it every three hours
• Fully enteral fed babies
• Milking the mother's milk with a milking machine
• The baby does not have a health problem that will require surgical treatment
• Breastfeeding of the mother's baby after discharge
• Of the birth percentile curves according to the gestational week of the baby.-90. among the percentile (those with a normal birth weight according to gestational age: Appropriate for Gestational Age -AGA) Dec.

You may not qualify if:

• According to the intrauterine growth curve, the baby's birth weight is low
• Feeding the baby with mama
• Total parenteral fed babies
• Discontinuation of mother's milk during the study process
• The mother's medication (antibiotics, etc.) to receive the treatment
• Those who have a small birth weight according to the gestational Age of the baby (Small for Gestational Age - SGA) and those who have a large birth weight according to the gestational age (Large for Gestational Age -LGA)

Sponsors & Collaborators

• Ayse Sonay Turkmen, Prof.Dr: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Karamanoğlu Mehmetbey University

Karaman, 70100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Milk, Human; Control Groups

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayşe S Türkmen

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 4, 2025
• Study Start: January 1, 2025
• Primary Completion: August 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)