Skip to main content
OpenTrials
Completed

NCT Number: NCT04992819

The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants

As in healthy term babies, the ideal food for preterm infants and sick term babies is breast milk. There are many studies indicating that the composition of breast milk can vary from mother to mother, according to the gestational week of the baby and gender. In new researches on breast milk content; It is argued that breast milk is different during the day and at night, that the micro and macro nutrient content, hormones and some enzymes show different levels of secretion at different times of the day, and that breast milk has a circadian rhythm.

This research is designed as a prospective, randomized, controlled type. The study will be carried out in order to evaluate the effect of Chronobiological Approach Nutrition Model application on baby's growth parameters and discharge time in preterm babies hospitalized in Neonatal Intensive Care Unit (NICU).

Simple randomization method will be used for the study and the babies will be divided into intervention(n=40) and control groups(n=40). The research was carried out with 80 babies followed up in the neonatal intensive care unit.

The milk of the intervention group patients will be matched circadian and given to the babies, the milk of the control group patients will be given without matching according to the clinical routine practice. Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breastfeeding Behavior Bottle Feeding Breast Feeding Chronobiology Disorders Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

32 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Women and Child Diseases Training and Research Hospital.

Istanbul, 34440, Turkey (Türkiye)

About this study

Circadian fluctuations in breast milk content are very important in preterm infants fed with expressed breast milk. The composition of breast milk varies throughout the day. In the literature, there is no randomized controlled study suggesting that the breast milk of infants fed with expressed milk should be matched to the baby circadian. In this study, it was aimed to evaluate the effect of Chronobiological Approach Model application on preterm infants growth parameters and discharge time in feeding of preterm infants hospitalized in the neonatal intensive care unit . It is aimed to accelerate the growth of babies by making circadian matching to breast milk in feeding preterm infants and to increase the quality of nursing practices by reducing the length of hospital stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Birth weight >1400 <2500 gram and gestational week ≥32-37 weeks
  • Who are feeding only human milk
  • Fully enterally fed babies (50-100ml / kg / day)
  • Whose parents signed the informed consent to participate in the study were included.

Exclusion criteria

  • Infants who cannot feed with human milk
  • Who receive intravenous fluid, total parenteral nutrition or mixed fluid
  • Infants with major congenital, cardiac, respiratory or airway abnormalities and infants who require additional pressure and respiratory support
  • Metabolic imbalances, hypoglycemia or electrolyte imbalance
  • Narcotic analgesic or sedation therapy
  • Whose parents did not sign the informed consent were excluded.

Treatment and study plan

Chronobiological Approach Nutrition Model

Procedure

In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.

Primary outcomes

  1. The effect of Chronobiological Approach Nutrition Model application on infants weight gain during circadian matched breastmilk

    Time frame: 30 minute

    Body weight gain- in kilograms

  2. The effect of Chronobiological Approach Nutrition Model application on infants height measured during circadian matched breastmilk

    Time frame: 30 minute

    Height-in meters

  3. The effect of Chronobiological Approach Nutrition Model application on infants head circumference during circadian matched breastmilk

    Time frame: 30 minute

    head circumference-in meters

  4. The effect of Chronobiological Approach Nutrition Model application on infants abdominal circumference during circadian matched breastmilk

    Time frame: 30 minute

    abdominal circumference-in meters

Secondary outcomes

  1. The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay

    Time frame: through study completion, an average of 30 days

    hospital stay- in days

  2. The effect of Chronobiological Approach Nutrition Model application on infant's growth parameters

    Time frame: through study completion, an average of 30 days

    Fenton's growth curves were used for determine percentile level in this research

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

The Effect of Oral Feeding Model With a Chronobiological Approach on Growth Parameters and Discharge Time in Preterm Infants: A Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2021
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.