BreastfeedingNCT04992819
The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants
A study testing Chronobiological Approach Nutrition Model in people with Breastfeeding and Bottle Feeding, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 37 weeks
- Conditions the study is for
- Breastfeeding, Bottle Feeding, Preterm
- What is being tested?
- Chronobiological Approach Nutrition Model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2020to 3 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Child Diseases Training and Research Hospital.
Istanbul, 34440
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Breastfeeding, Bottle Feeding, Preterm, Chronobiology Disorders
- Being tested
- Chronobiological Approach Nutrition Model
- Keywords
- breastfeeding, preterm infants, chronobiological, Human milk, Circadian rhythm, neonate
- Medical subject headings
- Breast Feeding, Bottle Feeding, Premature Birth, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronobiological Approach Nutrition ModelProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Chronobiological Approach Nutrition Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Chronobiological Approach Nutrition Model application on infants weight gain during circadian matched breastmilk
Body weight gain- in kilograms
Measured: 30 minute
The effect of Chronobiological Approach Nutrition Model application on infants height measured during circadian matched breastmilk
Height-in meters
Measured: 30 minute
The effect of Chronobiological Approach Nutrition Model application on infants head circumference during circadian matched breastmilk
head circumference-in meters
Measured: 30 minute
The effect of Chronobiological Approach Nutrition Model application on infants abdominal circumference during circadian matched breastmilk
abdominal circumference-in meters
Measured: 30 minute
Secondary outcomes (2)
The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay
hospital stay- in days
Measured: through study completion, an average of 30 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
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start29 Dec 2020
- Primary completion3 Jul 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled two groups (control group and experimental group)
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Temizsoy, Okan University
- Investigators
- Ebru Temizsoy, Principal investigator, Zeynep Kamil Women and Child Diseases Training and Research Hospital. İstanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992819
- Sponsor's protocol ID
- 25848687
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04992819
- Acronym / sponsor ID
- 25848687
- Conditions
- Breastfeeding, Bottle Feeding, Preterm, Chronobiology Disorders
- Keywords
- breastfeeding, preterm infants, chronobiological, Human milk, Circadian rhythm, neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled two groups (control group and experimental group)
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Chronobiological Approach Nutrition ModelPreterm 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. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronobiological Approach Nutrition ModelIn 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. | Procedure or surgery | Chronobiological Approach Nutrition Model |
Primary outcome
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
The effect of Chronobiological Approach Nutrition Model application on infants height measured during circadian matched breastmilk
Time frame: 30 minute
Height-in meters
The effect of Chronobiological Approach Nutrition Model application on infants head circumference during circadian matched breastmilk
Time frame: 30 minute
head circumference-in meters
The effect of Chronobiological Approach Nutrition Model application on infants abdominal circumference during circadian matched breastmilk
Time frame: 30 minute
abdominal circumference-in meters
2 secondary outcomes
The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay
Time frame: through study completion, an average of 30 days
The effect of Chronobiological Approach Nutrition Model application on infant's growth parameters
Time frame: through study completion, an average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Temizsoy principal investigator
Zeynep Kamil Women and Child Diseases Training and Research Hospital. İstanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronobiological Approach Nutrition Model in people with Breastfeeding and Bottle Feeding, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Chronobiological Approach Nutrition Model application on infants weight gain during circadian matched breastmilk (time frame: 30 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.