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Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

Primary Purpose

Nutrition, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
choronobiological nutrition
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nutrition, Healthy focused on measuring premature, chorobiological nutrition, Breastfeeding Processes

Eligibility Criteria

30 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being treated in the NICU Gestation week is between 30 and 36 The delivery took place in the hospital where the study was conducted. 70% of the daily enteral feeding is done with breast milk Exclusion Criteria: The baby is less than 30 weeks of gestation and greater than 36 weeks of gestation. Having neurological sequelae Having Grade 4 intraventricular bleeding The development of problems such as sepsis, NEC, which may change the general condition Being followed in invasive mechanical ventilation Receiving narcotic analgesics and sedation The baby has been shipped from outside Having undergone gastrointestinal (GIS) surgery or having GIS anomaly

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    choronobiological nutrition group

    control group

    Arm Description

    newborns were fed according to chronobiological nutrition

    newborns will be fed in the order in which breastmilk is delivered to the hospital

    Outcomes

    Primary Outcome Measures

    The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher.
    newborn was evaluated during hospital treatment

    Secondary Outcome Measures

    Weight gain of newborns will be evaluated using a questionnaire prepared by the investigator.
    newborn was evaluated during hospital treatment

    Full Information

    First Posted
    April 18, 2023
    Last Updated
    April 28, 2023
    Sponsor
    Eskisehir Osmangazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05849948
    Brief Title
    Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes
    Official Title
    The Effect of Chronobiological Nutritional Approach on Growth and Breastfeeding Processes of Premature Babies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. As a result of the power analysis using the G Power 3.0.10 program, 90% power; A total of at least 78 samples were found to be sufficient in the study with a 5% margin of error (n1: 39; n2: 39). However, considering that the case could be lost, it was decided to increase it by 20% to 94 babies. Infants will be assigned to groups using a stratified sequential block randomization method. Premature babies will be stratified by week of gestation, birth weight and sex, and then an equal number of babies will be assigned to each group by blocking. The appointment of premature infants will be decided by sequential block randomization. After the descriptive information of the babies assigned to the groups is recorded in the questionnaire, the experimental group will be fed by applying the chronobiological nutrition approach. The control group will be fed without applying the chronobiological nutrition approach. The discharge times will be calculated for both groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition, Healthy
    Keywords
    premature, chorobiological nutrition, Breastfeeding Processes

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    94 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    choronobiological nutrition group
    Arm Type
    Experimental
    Arm Description
    newborns were fed according to chronobiological nutrition
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    newborns will be fed in the order in which breastmilk is delivered to the hospital
    Intervention Type
    Behavioral
    Intervention Name(s)
    choronobiological nutrition
    Intervention Description
    Providing infant nutrition in accordance with crinobiological nutrition
    Primary Outcome Measure Information:
    Title
    The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher.
    Description
    newborn was evaluated during hospital treatment
    Time Frame
    The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
    Secondary Outcome Measure Information:
    Title
    Weight gain of newborns will be evaluated using a questionnaire prepared by the investigator.
    Description
    newborn was evaluated during hospital treatment
    Time Frame
    The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
    Other Pre-specified Outcome Measures:
    Title
    Height growth of newborns will be evaluated using a questionnaire prepared by the researcher.
    Description
    newborn was evaluated during hospital treatment
    Time Frame
    The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
    Title
    Head circumference of newborns will be evaluated using a questionnaire prepared by the researcher.
    Description
    newborn was evaluated during hospital treatment
    Time Frame
    The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
    Title
    The duration of breastfeeding of newborns by their mothers will be evaluated using a questionnaire prepared by the researcher.
    Description
    The newborn was evaluated in the first 6 months after discharge.
    Time Frame
    will be evaluated once a month for 6 months after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Weeks
    Maximum Age & Unit of Time
    36 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being treated in the NICU Gestation week is between 30 and 36 The delivery took place in the hospital where the study was conducted. 70% of the daily enteral feeding is done with breast milk Exclusion Criteria: The baby is less than 30 weeks of gestation and greater than 36 weeks of gestation. Having neurological sequelae Having Grade 4 intraventricular bleeding The development of problems such as sepsis, NEC, which may change the general condition Being followed in invasive mechanical ventilation Receiving narcotic analgesics and sedation The baby has been shipped from outside Having undergone gastrointestinal (GIS) surgery or having GIS anomaly
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ezgi Ayvaz
    Phone
    05423787400
    Email
    ezgiayvz@gmail.com

    12. IPD Sharing Statement

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    Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

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