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

NCT04992819 | Completed DMC

• 1 other identifier: 25848687
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Bottle Feeding; Preterm; Chronobiology Disorders

Keywords

breastfeeding; preterm infants; chronobiological; Human milk; Circadian rhythm; neonate

Outcome Measures

Primary Outcomes (4)

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

  Body weight gain- in kilograms

  30 minute

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

  Height-in meters

  30 minute

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

  head circumference-in meters

  30 minute

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

  abdominal circumference-in meters

  30 minute

Secondary Outcomes (2)

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

  through study completion, an average of 30 days

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

  through study completion, an average of 30 days

Study Arms (2)

Control Group

NO INTERVENTION

Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. Experiment is about labeling breast milk by time of day before giving it to babies. There is no extra intervention during feeding. The breastmilk 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.

Chronobiological Approach Nutrition Model

EXPERIMENTAL

Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. The milk of the intervention group patients will be matched circadian and given to the babies. Intervention group's breast milk is labeling by time of day before the each feeding. In the intervention group, a label containing the time of expressed breastmilk will be affixed. Circadian matched milk will be provided at each feeding. intervention is;n 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. Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Procedure: Chronobiological Approach Nutrition Model

Interventions

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.

Chronobiological Approach Nutrition Model

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Zeynep Kamil Women and Child Diseases Training and Research Hospital.

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding; Bottle Feeding; Premature Birth; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nervous System Diseases

Study Officials

• Ebru Temizsoy

  Zeynep Kamil Women and Child Diseases Training and Research Hospital. İstanbul, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Princiciple İnvestigator, RN, MSc

Model Details: Randomized Controlled two groups (control group and experimental group)

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: August 5, 2021
• Study Start: December 29, 2020
• Primary Completion: July 3, 2021
• Study Completion: July 3, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)