Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients

NCT06342674 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-05-01

No results posted yet for this study

Summary

The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.

no effect on the infant's growth parameters and nutrient absorption levels by the infant.

Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.

Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.

Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.

Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk.

Conditions

  • Breast Feeding
  • Breast Milk Collection

Interventions

OTHER

Giving breast milk to the newborn according to the circadian rhythm

It is the delivery of milk expressed by the newborn's mother during the neonatal intensive care unit, in accordance with the time of expression. Breast milk follows the circadian rhythm, that is, the milk the mother expresses at night will be given to her infant at night, and the milk she expresses during the day will be given to her infant during the day

OTHER

Usual care

Newborns in the control group will be given expressed milk first, in line with the routine practice of the clinic

Sponsors & Collaborators

  • Sakarya University

    lead OTHER

Principal Investigators

  • Nejla Canbulat Şahiner, Prof.Dr. · Karamanoğlu Mehmet Bey University

  • Ayşe Sonay Türkmen, Prof. Dr. · Karamanoğlu Mehmet Bey University

  • Dilek Menekşe, Asst. prof. · Sakarya University

  • Hacer Sibel Karapınar, Assoc. Prof. · Karamanoğlu Mehmet Bey University

  • Murat Konak, Assoc. Prof. · Selçuk University

  • Havvanur Bayam, Nutritionist · Selçuk University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-25
Primary Completion
2025-04-01
Completion
2025-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06342674 on ClinicalTrials.gov