NCT06857149

Effect of Cırcadıan Feedıng on Growth Parameters of Preterm Newborn

Active, enrolled NA Last updated 4 March 2025

What this trial tests

NA trial testing Human milk in Milk Expression, Breast in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2025

Primary endpoint
31 August 2025

1 June 2026

Quick facts

Lead sponsor	Ayse Sonay Turkmen, Prof.Dr
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	48
Start date	1 January 2025
Primary completion	31 August 2025
Estimated completion	1 June 2026
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Human milk
• Control Group — full drug profile →

Conditions studied

• Milk Expression, Breast — all drugs for Milk Expression, Breast →
• Nutrition — all drugs for Nutrition →

Sponsor

Ayse Sonay Turkmen, Prof.Dr

Who can join

Adults 32 Weeks to 34 Weeks, any sex, with Milk Expression, Breast or Nutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.