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

Primary Purpose

Breastfeeding, Bottle Feeding, Preterm

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Chronobiological Approach Nutrition Model
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breastfeeding focused on measuring breastfeeding, preterm infants, chronobiological, Human milk, Circadian rhythm, neonate

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zeynep Kamil Women and Child Diseases Training and Research Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Chronobiological Approach Nutrition Model

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The effect of Chronobiological Approach Nutrition Model application on infants weight gain during circadian matched breastmilk
Body weight gain- in kilograms
The effect of Chronobiological Approach Nutrition Model application on infants height measured during circadian matched breastmilk
Height-in meters
The effect of Chronobiological Approach Nutrition Model application on infants head circumference during circadian matched breastmilk
head circumference-in meters
The effect of Chronobiological Approach Nutrition Model application on infants abdominal circumference during circadian matched breastmilk
abdominal circumference-in meters

Secondary Outcome Measures

The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay
hospital stay- in days
The effect of Chronobiological Approach Nutrition Model application on infant's growth parameters
Fenton's growth curves were used for determine percentile level in this research

Full Information

First Posted
July 4, 2021
Last Updated
July 29, 2021
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT04992819
Brief Title
The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants
Official Title
The Effect of Oral Feeding Model With a Chronobiological Approach on Growth Parameters and Discharge Time in Preterm Infants: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
July 3, 2021 (Actual)
Study Completion Date
July 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Bottle Feeding, Preterm, Chronobiology Disorders
Keywords
breastfeeding, preterm infants, chronobiological, Human milk, Circadian rhythm, neonate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled two groups (control group and experimental group)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Chronobiological Approach Nutrition Model
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Chronobiological Approach Nutrition Model
Intervention Description
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 Outcome Measure Information:
Title
The effect of Chronobiological Approach Nutrition Model application on infants weight gain during circadian matched breastmilk
Description
Body weight gain- in kilograms
Time Frame
30 minute
Title
The effect of Chronobiological Approach Nutrition Model application on infants height measured during circadian matched breastmilk
Description
Height-in meters
Time Frame
30 minute
Title
The effect of Chronobiological Approach Nutrition Model application on infants head circumference during circadian matched breastmilk
Description
head circumference-in meters
Time Frame
30 minute
Title
The effect of Chronobiological Approach Nutrition Model application on infants abdominal circumference during circadian matched breastmilk
Description
abdominal circumference-in meters
Time Frame
30 minute
Secondary Outcome Measure Information:
Title
The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay
Description
hospital stay- in days
Time Frame
through study completion, an average of 30 days
Title
The effect of Chronobiological Approach Nutrition Model application on infant's growth parameters
Description
Fenton's growth curves were used for determine percentile level in this research
Time Frame
through study completion, an average of 30 days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Temizsoy
Organizational Affiliation
Zeynep Kamil Women and Child Diseases Training and Research Hospital. İstanbul, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeynep Kamil Women and Child Diseases Training and Research Hospital.
City
İstanbul
ZIP/Postal Code
34440
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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