Tandem BreastfeedingBreastfeedingNCT04514809
Milk Compositions of Mothers Who Breastfeed as Tandem
A study testing human milk analized in people with Tandem Breastfeeding, run by Sakarya University.
Trial summary
The impact of tandem breastfeeding on the health of mothers and babies is a matter of curiosity. It is stated in the literature that there are few studies that examine the results of tandem breastfeeding in terms of mother, newborn and other baby after birth, and that there are no negative consequences of… Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tandem Breastfeeding
- What is being tested?
- human milk analized
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being mature newborn (<37 GW) Being a mother who in third trimester The mother's lack of a health problem from a metabolic and endocrine perspective related to nutrition Absence of diagnosed psychiatric story of the mother Mother's openness to communication and cooperation Mother's volunteering to participate in the study Mother being literate Having multigravida of the mother Mother's age above 18 years Being a mother non-vegetarian Being a mother non-smoker Absence of breast trauma in mother (mastitis, abscess etc.) Mother's milk analysis at least a week before without taking any medication Having body mass index at normal values (18.5 to 24.9) pre-pregnancy (WHO, 2015).
Who cannot join
- Having a condition that obstacle for breastfeeding (craniofacial abnormality such as cleft palate, cleft lip, paralysis of facial muscles)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Milk Compositions of Tandem Breastfeeding Mothers With Milk Compositions of Single Infant Breastfeeding Mothers: Randomized Controlled Trial
The impact of tandem breastfeeding on the health of mothers and babies is a matter of curiosity. It is stated in the literature that there are few studies that examine the results of tandem breastfeeding in terms of mother, newborn and other baby after birth, and that there are no negative consequences of breastfeeding in terms of mother, newborn and older baby at two different ages. Research shows that while it is possible for mothers to continue breastfeeding by counselling to them based on evidence-based information, most of them have ended breastfeeding. It is the responsibility of nurses to make this process more successful and seamless for both mothers and babies. In tandem breastfeeding, the nurse should advise the mother on her own feeding and breastfeeding, and should refer her to her physician if she considers it necessary. There is no clear and up - to-date source showing changes in mother's milk over time (24-72 hours-one month), production time (colostrum and mature milk), changes in milk composition in tandem breastfeeding in the current literature, and this study is original with this aspect.
Read the detailed description
Background: Considering the health benefits both for the infant and the mother, American Academy of Pediatrics (AAP) and World Health Organization (WHO) recommend only mother's milk in the first six months of life and then continuing breastfeeding for at least two years with complementary feeding (Eidelman, 2012; Topal et al., 2011). A review of the breastfeeding status of babies in Turkey reveals that breastfeeding is common, but it is not at a satisfactory level in terms of the length of time babies are given mother's milk only or in the total length of breastfeeding. One of the most important reasons is early start of complementary food or early weaning (TNSA2018). In 5.7 to 29.2% of the cases where breastfeeding was terminated early, the mother became pregnant again during the lactation period. Both mothers and healthcare professionals are confused as to whether breastfeeding should continue in pregnancy. Moreover, the field literature does not offer any information about any changes in the milk composition of a mother breastfeeding two babies of different ages at the same time (tandem breastfeeding). It is also known that some mothers who get pregnant during lactation period or with an interval of less than two years do not wean the first-born and continue breastfeeding both babies at the same time (Bøhler \& Ingstad, 1996; Moscone \& Moore, 1993; O'Rourke \& Spatz, 2019). In light of this information, this study project is aimed to explore any differences in the composition (fat, protein, lactose, water, and casein) and density of milk during pregnancy or tandem breastfeeding.
Method: The universe of the study is planned to consist of all multigravid women admitted to the Obstetrics and Gynecology Clinic of the Sakarya University Education and Research Hospital, Turkey, breastfeeding postpartum in tandem and not breastfeeding during pregnancy. The sample of the study, including 15 control and 15 experimental groups, 30 mothers to be selected according to the inclusion criteria. groups will be determined by simple random sampling method. In order to assign the mothers who meet the selection criteria into the experimental group or the control group, the randomization method with a computer program (http://www1.assumption.edu/users/ avadum/applets/RandAssin/Groupgen.html) was used. Data collection is planned to take place in two stages for control and experimental groups. The first stages correspond to 24 to 72 hours postpartum. This is to be accomplished through house calls upon appointment with the mothers. During the house call, 15 ml milk is obtained from the mother with suitable methods (Appendix…) and preserved in a sterilized milk collection container. At the end of birth, 15 ml colostrum will be taken from the mother, instead of 30 ml, so that the babies in both groups benefit more from colostrum. Then, it is analyzed within the next 3 hours in terms of its composition (moisture, protein, oil, lactose) and to the Tubitak Mam Research Center to the Nutrition Lab for analysis.Results are recorded in the "Breastfeeding Follow-up Form." The final stages (after the 1st month postpartum), during the house call, 30 ml milk is obtained from the mother with suitable methods (Appendix…) and preserved in a sterilized milk collection container, other steps will be repeated in the same order. The results of the analysis will be compared with the breast milk compositions in the control group. The results of this study are expected to clarify the attitudes of healthcare professionals about tandem breastfeeding and to draw attention to this issue, thereby providing guidance and encouragement for further studies on the subject..
- Conditions
- Tandem Breastfeeding
- Being tested
- human milk analized
- Keywords
- Breastfeeding in pregnancy, tandem breastfeeding, human milk composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human milk analizedOther
After birth (24-72 hours) 15 ml, and end of the first month of birth 30 ml of milk from the mother will be milked in the appropriate way and put into the sterile milk collection container. The milk taken into the milk transport container will be delivered to the Nutrition Lab for analysis (moisture, protein, fat, lactose) by the researcher who arrives at the TUBITAK Mam Research Center as fresh within 3 hours
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | It consists of 15 mothers who meet the inclusion criteria Receives: Other: human milk analized |
| Control Groups | Experimental | It consists of 15 mothers who meet the inclusion criteria Receives: Other: human milk analized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the protein level of breast milk in study and control groups
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers.
Measured: 24 to 72 hours postpartum and of the 1st month postpartum
Evaluation of breast milk fat level in study and control group
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers
Measured: of the 1st month postpartum
Evaluation of lactose level of breast milk in study and control group
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers.
Measured: of the 1st month postpartum
Evaluation of moisture level of breast milk in study and control group
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers.
Measured: of the 1st month postpartum
Secondary outcomes (1)
Feeding follow-up of mothers
This form is the form in which the participants recorded all the nutrients they had consumed in the last three days as six meals, with three main and three intermediates. Information will be provided to the participants by the researcher (O.K.S.) about how to record the amounts of all the food and drink they consumed in the last three days with standard sizes such as units, numbers, grams, water or tea cups, cups, etc. Forms will be distributed in order to record all the nutrients they consume in the same day regularly as meals and collected back on home visit days. With this form, the daily consumption amounts of energy, vitamins, minerals, protein, fat, carbohydrates, fiber and beverages will be analyzed in the nutrition information system (Bebis 8.0) software package program.
Measured: 24 to 72 hours postpartum and the 1st month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tandem BreastfeedingStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursan Cinar, Sakarya University
- Investigators
- Nursan Cinar, PhD, Study director, Sakarya Universityözge suzan, Msc, Principal investigator, Sakarya Universityserhan cevrioglu, PhD, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514809
- Sponsor's protocol ID
- Nursan CİNAR
- Acronym
- Breastfeeding
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Milk Compositions of Tandem Breastfeeding Mothers With Milk Compositions of Single Infant Breastfeeding Mothers: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04514809
- Acronym / sponsor ID
- Breastfeeding / Nursan CİNAR
- Conditions
- Tandem Breastfeeding
- Keywords
- Breastfeeding in pregnancy, tandem breastfeeding, human milk composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 17 Aug 2020 (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.
The impact of tandem breastfeeding on the health of mothers and babies is a matter of curiosity. It is stated in the literature that there are few studies that examine the results of tandem breastfeeding in terms of mother, newborn and other baby after birth, and that there are no negative consequences of breastfeeding in terms of mother, newborn and older baby at two different ages. Research shows that while it is possible for mothers to continue breastfeeding by counselling to them based on evidence-based information, most of them have ended breastfeeding. It is the responsibility of nurses to make this process more successful and seamless for both mothers and babies. In tandem breastfeeding, the nurse should advise the mother on her own feeding and breastfeeding, and should refer her to her physician if she considers it necessary. There is no clear and up - to-date source showing changes in mother's milk over time (24-72 hours-one month), production time (colostrum and mature milk), changes in milk composition in tandem breastfeeding in the current literature, and this study is original with this aspect.
Detailed description
Background: Considering the health benefits both for the infant and the mother, American Academy of Pediatrics (AAP) and World Health Organization (WHO) recommend only mother's milk in the first six months of life and then continuing breastfeeding for at least two years with complementary feeding (Eidelman, 2012; Topal et al., 2011). A review of the breastfeeding status of babies in Turkey reveals that breastfeeding is common, but it is not at a satisfactory level in terms of the length of time babies are given mother's milk only or in the total length of breastfeeding. One of the most important reasons is early start of complementary food or early weaning (TNSA2018). In 5.7 to 29.2% of the cases where breastfeeding was terminated early, the mother became pregnant again during the lactation period. Both mothers and healthcare professionals are confused as to whether breastfeeding should continue in pregnancy. Moreover, the field literature does not offer any information about any changes in the milk composition of a mother breastfeeding two babies of different ages at the same time (tandem breastfeeding). It is also known that some mothers who get pregnant during lactation period or with an interval of less than two years do not wean the first-born and continue breastfeeding both babies at the same time (Bøhler \& Ingstad, 1996; Moscone \& Moore, 1993; O'Rourke \& Spatz, 2019). In light of this information, this study project is aimed to explore any differences in the composition (fat, protein, lactose, water, and casein) and density of milk during pregnancy or tandem breastfeeding.
Method: The universe of the study is planned to consist of all multigravid women admitted to the Obstetrics and Gynecology Clinic of the Sakarya University Education and Research Hospital, Turkey, breastfeeding postpartum in tandem and not breastfeeding during pregnancy. The sample of the study, including 15 control and 15 experimental groups, 30 mothers to be selected according to the inclusion criteria. groups will be determined by simple random sampling method. In order to assign the mothers who meet the selection criteria into the experimental group or the control group, the randomization method with a computer program (http://www1.assumption.edu/users/ avadum/applets/RandAssin/Groupgen.html) was used. Data collection is planned to take place in two stages for control and experimental groups. The first stages correspond to 24 to 72 hours postpartum. This is to be accomplished through house calls upon appointment with the mothers. During the house call, 15 ml milk is obtained from the mother with suitable methods (Appendix…) and preserved in a sterilized milk collection container. At the end of birth, 15 ml colostrum will be taken from the mother, instead of 30 ml, so that the babies in both groups benefit more from colostrum. Then, it is analyzed within the next 3 hours in terms of its composition (moisture, protein, oil, lactose) and to the Tubitak Mam Research Center to the Nutrition Lab for analysis.Results are recorded in the "Breastfeeding Follow-up Form." The final stages (after the 1st month postpartum), during the house call, 30 ml milk is obtained from the mother with suitable methods (Appendix…) and preserved in a sterilized milk collection container, other steps will be repeated in the same order. The results of the analysis will be compared with the breast milk compositions in the control group. The results of this study are expected to clarify the attitudes of healthcare professionals about tandem breastfeeding and to draw attention to this issue, thereby providing guidance and encouragement for further studies on the subject..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: human milk analizedIt consists of 15 mothers who meet the inclusion criteria |
| Control Groups | Experimental | Other: human milk analizedIt consists of 15 mothers who meet the inclusion criteria |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being mature newborn (<37 GW) Being a mother who in third trimester The mother's lack of a health problem from a metabolic and endocrine perspective related to nutrition Absence of diagnosed psychiatric story of the mother Mother's openness to communication and cooperation Mother's volunteering to participate in the study Mother being literate Having multigravida of the mother Mother's age above 18 years Being a mother non-vegetarian Being a mother non-smoker Absence of breast trauma in mother (mastitis, abscess etc.) Mother's milk analysis at least a week before without taking any medication Having body mass index at normal values (18.5 to 24.9) pre-pregnancy (WHO, 2015).
Key exclusion criteria (1 listed)
- Having a condition that obstacle for breastfeeding (craniofacial abnormality such as cleft palate, cleft lip, paralysis of facial muscles)
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 |
|---|---|---|
| human milk analizedAfter birth (24-72 hours) 15 ml, and end of the first month of birth 30 ml of milk from the mother will be milked in the appropriate way and put into the sterile milk collection container. The milk taken into the milk transport container will be delivered to the Nutrition Lab for analysis (moisture, protein, fat, lactose) by the researcher who arrives at the TUBITAK Mam Research Center as fresh within 3 hours | Other | Control Groups, Experimental |
Primary outcome
Evaluation of the protein level of breast milk in study and control groups
Time frame: 24 to 72 hours postpartum and of the 1st month postpartum
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers.
Evaluation of breast milk fat level in study and control group
Time frame: of the 1st month postpartum
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers
Evaluation of lactose level of breast milk in study and control group
Time frame: of the 1st month postpartum
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers.
Evaluation of moisture level of breast milk in study and control group
Time frame: of the 1st month postpartum
The measurement values will be recorded on the "mother milk follow form" which was created by the researchers.
1 secondary outcome
Feeding follow-up of mothers
Time frame: 24 to 72 hours postpartum and the 1st month postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
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.
Nursan Cinar, PhD study director
Sakarya University
özge suzan, Msc principal investigator
Sakarya University
serhan cevrioglu, PhD principal investigator
Sakarya University
Questions about this trial
What is this clinical trial studying?
A study testing human milk analized in people with Tandem Breastfeeding, run by Sakarya 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 1 inclusion and 1 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 17 Aug 2020. 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 özge suzan, MsC (02642954341, ozgekarakayasuzan@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the protein level of breast milk in study and control groups (time frame: 24 to 72 hours postpartum and of the 1st month postpartum). 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 17 Aug 2020.