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The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns

S

Selcuk University

Status

Enrolling

Conditions

Hospitalization
Breast Feeding, Exclusive
Feeding Patterns

Treatments

Other: Feeding model group with a chronobiological approach

Study type

Interventional

Funder types

Other

Identifiers

NCT05923437
SelcukUnı42

Details and patient eligibility

About

This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.

Full description

The newborn period is a period when all babies need their basic needs to be met and all babies are very sensitive physiologically, neuro-biologically and psycho-emotionally, but the newborn period is also a very important period in the development of circadian rhythm. It is important to establish a healthy sleep pattern for the formation of the circadian rhythm and the continuation of the functions of all other systems, especially the central nervous system. Formation of circadian rhythm in newborns; It shows a better development in the first 3 months with the effect of environmental factors such as nutrition, light, mother-baby interaction. Breast milk is a nutrient for the growth and development of babies, in addition, breast milk plays an active role in the formation of the baby's circadian rhythm by transmitting information about the time of day to the babies through components such as hormones and immune elements. In cases where breastfeeding is not possible, it is thought that the delivery of expressed breast milk to the babies simultaneously with the "feeding model with a chronobiological approach" has important effects on the sleep-wake cycle and growth and development. In studies examining circadian rhythm in newborns in the world and in our country, the limited number of studies evaluating the relationship between circadian rhythm and breast milk draws attention and further studies are recommended. However, there is no published study evaluating the effect of simultaneous administration of breast milk to the infant in line with the "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.

Enrollment

40 estimated patients

Sex

All

Ages

28 to 42 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gestational age between 28-42 weeks
  • Birth weight between 1500 and 4200 gr
  • Hospitalization for at least 3 days
  • Exclusive breastfeeding (oral/ enteral)
  • Feeding at 3-hour intervals
  • Stable health condition
  • Spontaneous breathing

Exclusion criteria

  • Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
  • 5th minute apgar score below 4 at the time of delivery
  • Resuscitation requirement
  • Having a congenital anomaly
  • Interventional intervention in the head region
  • Central nervous system dysfunction
  • Postpartum medical complications

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Experimental: Interventions Group
Experimental group
Description:
Breast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiological approach", simultaneously with the mother's supply.
Treatment:
Other: Feeding model group with a chronobiological approach
Control Group
No Intervention group
Description:
Breast milk will be given to newborns in the control group according to the clinical routine and infants will be followed up for 3 days.

Trial contacts and locations

2

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Central trial contact

Sibel Kucukoglu

Data sourced from clinicaltrials.gov

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