Breast FeedingNCT04158999
Investigation of the Effect of Mother's Nutrition Status on Breast Milk Contents
An observational study of Breast Feeding, run by Halic University.
Trial summary
This study; this work; The aim is to investigate the effects of mothers' nutritional status on breast milk macro nutrients (carbohydrate, fat and protein). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- milk analyzer and Mother's nutrition values
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2019to 12 May 2020
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mothers whose babies were followed in the neonatal follow-up outpatient clinic of the Neonatal Intensive Care Unit of Istanbul University Faculty of Medicine, Department of Pediatrics and Fifty will be composed of 50 mothers who meet the sample selection criteria.
Who may be able to join
- Follow-up of the infant in the Neonatal Intensive Care Unit, Istanbul Faculty of Medicine, Department of Pediatrics,
- The mother is able to understand and answer the questions,
- Single pregnancy,
- The baby's birth week is 34 weeks or more,
- The mother does not have a disease (Diabetes, hypertension, hypothyroidism, etc.) that may affect breast milk content.
Who cannot join
- Multiple pregnancy,
- The birth week of the baby is less than 34 weeks.
- Breastfeeding or breast problems in the mother,
- The mother has a disease that may affect breast milk content (Diabetes, hypertension, hypothyroidism, etc.),
- The mother is not willing to participate in the research,
- A disease known to be transmitted by breast milk (HIV, hepatitis B, hepatitis C, etc.).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Descriptive, Observational, Investigation of the Effect of Mother's Nutrition Status on Breast Milk Contents
This study; this work; The aim is to investigate the effects of mothers' nutritional status on breast milk macro nutrients (carbohydrate, fat and protein).
Read the detailed description
Macronutrients in breast milk can be affected by various factors. The mothers will be taken in the first 24 hours after birth and their nutritional habits, socio-demographic characteristics, anthropometric characteristics of the mother, body mass index will be examined and newborn characteristics will be taken. 2 ml sample from colostrum will be analyzed with milk analyzer instrument. The mothers will be re-checked on the 5th day and their anthropometric properties will be obtained. The same procedure will be repeated on the 15th day after childbirth. At each control, the mother's last 24-hour feeding status will be taken and the nutritional values consumed by "BeBis" program will be examined.
- Conditions
- Breast Feeding
- Being tested
- milk analyzer, Mother's nutrition values
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk analyzerDevice
Also called Human Milk Sample
Human Milk Sample
Mother's nutrition valuesBehavioural
evaluation of nutritional elements of maternal onset with Bebis Program
| Study group | Role | What they receive |
|---|---|---|
| Mother milk | Step 1: Mothers who meet the sample selection criteria will be informed about the scope of the study and their written and verbal consent will be obtained. Data collection form will be applied to mothers who accept to participate in the study by using face to face interview technique. Mothers and newborns will be weighed and 4 ml breast milk sample will be taken from the mother for manual milking. Receives: Device: milk analyzer; Behavioral: Mother's nutrition values |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Milk Macro Nutrients
CHA,Protein, Fat
Measured: 15 Days
Secondary outcomes (1)
Mother's Diet
BMI
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start10 Nov 2019 (estimated)
- Primary completion12 Feb 2020 (estimated)
- Study completion12 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Fatma Şule Bilgiç, Halic University
- Investigators
- Gulçin Bozkurt, Assc. Prof., Study director, Istanvbul University-CerrahpasaAsuman Çoban, Prof, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158999
- Sponsor's protocol ID
- SuleTez
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The population of the study will be composed of mothers whose babies are followed in the neonatal follow-up outpatient clinic of the Neonatal Intensive Care Unit of Istanbul University Faculty of Medicine, Department of Child Health and Diseases. data collection form total of 69 questions; women's socio-demographic characteristics11 questions, baby's characteristics and nutrition10 questions, obstetric characteristics of pregnancy, curettage, abortion, childbirth 11 obstetric questions, features related to breastfeeding 8 questions, the mother's feeding habits 5 questions and 24 questions about the results of the mother's milk sample It is a daily (last 24 hours) form of food consumption which is required to indicate the foods consumed in the last 24 hours before. Data collection tools will be applied using face to face interview technique.
Publications
Butts CA, Hedderley DI, Herath TD, Paturi G, Glyn-Jones S, Wiens F, Stahl B, Gopal P. Human Milk Composition and Dietary Intakes of Breastfeeding Women of Different Ethnicity from the Manawatu-Wanganui Region of New Zealand. Nutrients. 2018 Sep 4;10(9):1231. doi: 10.3390/nu10091231.
PubMed 30181524Bravi F, Wiens F, Decarli A, Dal Pont A, Agostoni C, Ferraroni M. Impact of maternal nutrition on breast-milk composition: a systematic review. Am J Clin Nutr. 2016 Sep;104(3):646-62. doi: 10.3945/ajcn.115.120881. Epub 2016 Aug 17.
PubMed 27534637
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive, Observational, Investigation of the Effect of Mother's Nutrition Status on Breast Milk Contents
- ClinicalTrials.gov ID
- NCT04158999
- Acronym / sponsor ID
- SuleTez
- Conditions
- Breast Feeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 10 Nov 2019 (estimated)
- Primary completion
- 12 Feb 2020 (estimated)
- Study completion
- 12 May 2020 (estimated)
- First posted
- 12 Nov 2019 (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.
This study; this work; The aim is to investigate the effects of mothers' nutritional status on breast milk macro nutrients (carbohydrate, fat and protein).
Detailed description
Macronutrients in breast milk can be affected by various factors. The mothers will be taken in the first 24 hours after birth and their nutritional habits, socio-demographic characteristics, anthropometric characteristics of the mother, body mass index will be examined and newborn characteristics will be taken. 2 ml sample from colostrum will be analyzed with milk analyzer instrument. The mothers will be re-checked on the 5th day and their anthropometric properties will be obtained. The same procedure will be repeated on the 15th day after childbirth. At each control, the mother's last 24-hour feeding status will be taken and the nutritional values consumed by "BeBis" program will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother milk | – | Device: milk analyzer, Behavioral: Mother's nutrition valuesStep 1: Mothers who meet the sample selection criteria will be informed about the scope of the study and their written and verbal consent will be obtained. Data collection form will be applied to mothers who accept to participate in the study by using face to face interview technique. Mothers and newborns will be weighed and 4 ml breast milk sample will be taken from the mother for manual milking. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers whose babies were followed in the neonatal follow-up outpatient clinic of the Neonatal Intensive Care Unit of Istanbul University Faculty of Medicine, Department of Pediatrics and Fifty will be composed of 50 mothers who meet the sample selection criteria.
Key inclusion criteria (5 listed)
- Follow-up of the infant in the Neonatal Intensive Care Unit, Istanbul Faculty of Medicine, Department of Pediatrics,
Key exclusion criteria (6 listed)
- Multiple pregnancy,
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 |
|---|---|---|
| milk analyzerAlso: Human Milk SampleHuman Milk Sample | Device | Mother milk |
| Mother's nutrition valuesevaluation of nutritional elements of maternal onset with Bebis Program | Behavioural | Mother milk |
Primary outcome
Human Milk Macro Nutrients
Time frame: 15 Days
CHA,Protein, Fat
1 secondary outcome
Mother's Diet
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Background: PubMed 30181524Butts CA, Hedderley DI, Herath TD, Paturi G, Glyn-Jones S, Wiens F, Stahl B, Gopal P. Human Milk Composition and Dietary Intakes of Breastfeeding Women of Different Ethnicity from the Manawatu-Wanganui Region of New Zealand. Nutrients. 2018 Sep 4;10(9):1231. doi: 10.3390/nu10091231.
- Results publication: PubMed 27534637Bravi F, Wiens F, Decarli A, Dal Pont A, Agostoni C, Ferraroni M. Impact of maternal nutrition on breast-milk composition: a systematic review. Am J Clin Nutr. 2016 Sep;104(3):646-62. doi: 10.3945/ajcn.115.120881. Epub 2016 Aug 17.
- Individual participant dataSharing planned: Yes. The population of the study will be composed of mothers whose babies are followed in the neonatal follow-up outpatient clinic of the Neonatal Intensive Care Unit of Istanbul University Faculty of Medicine, Department of Child Health and Diseases. data collection form total of 69 questions; women's socio-demographic characteristics11 questions, baby's characteristics and nutrition10 questions, obstetric characteristics of pregnancy, curettage, abortion, childbirth 11 obstetric questions, features related to breastfeeding 8 questions, the mother's feeding habits 5 questions and 24 questions about the results of the mother's milk sample It is a daily (last 24 hours) form of food consumption which is required to indicate the foods consumed in the last 24 hours before. Data collection tools will be applied using face to face interview technique.
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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.
Gulçin Bozkurt, Assc. Prof. study director
Istanvbul University-Cerrahpasa
Asuman Çoban, Prof study director
Istanbul University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by Halic University.
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 5 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: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Sule Tanrıverdi, MsC Student (05413606482, sulebilgicc@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Milk Macro Nutrients (time frame: 15 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158999, which also lists 2 linked publications.
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 12 Nov 2019.