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NCT05338203
Comparison of Breast Milk Contents in Tandem Breastfeeding and Non-Tandem Breastfeeding Mother
NA trial testing tandem breastfeedıng in Tandem Breastfeeding in 36 participants. Status unknown.
15 May 2022
Quick facts
| Lead sponsor | Gazi University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 36 |
| Start date | 15 April 2022 |
| Primary completion | 15 May 2022 |
| Estimated completion | 30 May 2022 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- tandem breastfeedıng
Conditions studied
- Tandem Breastfeeding — all drugs for Tandem Breastfeeding →
Sponsor
Gazi University
Who can join
Eligibility, female only, with Tandem Breastfeeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breastfeeding is the gold standard for feeding newborns and infants. Tandem breastfeeding is defined as breastfeeding during pregnancy or simultaneous breastfeeding of two non-twins. The aim of this study; The aim of this study is to compare breast milk contents of mothers who breastfeed in tandem and mothers who do not breastfeed in tandem. The study was planned as an experimental study with a single center control group. The place where the research will be conducted is the Lactation/Relactation outpatient clinic and gynecology and obstetrics polyclinic of Çamlıca Medipol University Hospital and Halil Şıvgın Çubuk State Hospital. and tandem non-breastfeeding mothers. Power analysis was performed to determine the number of samples. For this purpose, the study results of Rosenberg et al. (2021) (Experiment: 8.1±0.2 Control:6.2±1.5) were used as reference. According to the power analysis made by calculating the effect size, the sample size calculated with α= 0.01 error level and 99% power; 18 women in the experimental group and 18 women in the control group, a total of at least 36 women. The analysis was made in G\*Power version 3.1.9.4. All mothers will be informed about the study, and mothers who accept the study will have to fill out the "Conformity to Criteria Form" created by the researchers. Written informed consent will be obtained from mothers who meet the research criteria. After completing the introductory information form, milk will be collected from all mothers. Milk collection will be done by one of the researchers. Milking will always be collected from all mothers between 08:00 and 16:00, provided that at least 40 minutes have passed after the last milking. Manual milking will be done for 10 minutes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05338203 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gazi University
- Last refreshed: 21 April 2022
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