Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05338203 |
| Other study ID # |
10840098 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2022 |
| Est. completion date |
May 30, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Gazi University |
| Contact |
Sidika PELIT AKSU, PhD |
| Phone |
+905069583180 |
| Email |
sidikapelit[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
There are studies on the concentration of macronutrients in breast milk in the literature A
few studies have examined macronutrients in breast milk in mothers who breastfeed in tandem.
Sinkiewicz-Darol et al. (2021) in his study; Macronutrients in breast milk in mothers who
breastfeed in tandem have been studied. Breast milk during tandem breastfeeding had higher
fat content, energy value, and total protein concentration than milk after weaning the older
child. The carbohydrate content remained constant. In the study of Rosenberg et al., (2021),
the concentration of macronutrients in breast milk was investigated in tandem breastfeeding
and non-tandem breastfeeding mothers. As a result, it was determined that breast milk
produced during pregnancy has different macronutrient content than breast milk produced after
birth. It was determined that colostrum and mature milk of mothers who breastfed in tandem
were similar to the milk of mothers who did not breastfeed in tandem, except for the
carbohydrate content. Breastfeeding and tandem breastfeeding during pregnancy have not been
extensively studied. For this reason, our study will determine the effect of tandem
breastfeeding on the macronutrient content of breast milk and will provide evidence for
tandem breastfeeding, which is traditionally practiced by many women.
1.2 Purpose of Research The aim of this study; The aim of this study is to compare the breast
milk contents of tandem breastfeeding and non-tandem breastfeeding mothers.
2. METHODS and MATERIALS 2.1. Type of Research The research was planned as an experimental
study with a single center control group.
2.2. Place of Research The place where the research will be carried out is the
Lactation/Relactation polyclinic and gynecology and obstetrics polyclinic of Çamlıca Medipol
University Hospital and Halil Şıvgın Çubuk State Hospital.
2.3. Sample of the Research The population of the study will be tandem breastfeeding and
non-tandem breastfeeding mothers who applied to the Lactation/Relactation outpatient clinic
of Çamlıca Medipol University Hospital and Halil Şıvgın Çubuk State Hospital, and the
obstetrics and gynecology outpatient clinics. 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 performed in G*Power version 3.1.9.4.
2.3.3. Example Selection Criteria All women who meet the following criteria will be invited
to participate in the study.
Experiment:
- If pregnant, being in the second trimester of pregnancy; have given birth, postpartum
16th day or more
- If pregnant, not having a risky pregnancy
- If she is pregnant, there is a report from the obstetrician she is followed that there
is no harm in breastfeeding
- The older child being breastfed is under the age of 2
- Absence of literacy problems, mental disabilities and communication problems
- Absence of chronic disease
- No communicable disease
- Not using a drug continuously
- Not using any medication in the last 24 hours
- Willingness to participate in the study
Control:
- Postpartum 16th day and above
- No risky pregnancy in her last pregnancy
- Being multiparous
- Absence of literacy problems, mental disabilities and communication problems
- Absence of chronic disease
- No communicable disease
- Not using a drug continuously
- Not using any medication in the last 24 hours
- Willingness to participate in the study During the research process, mothers will be
excluded from the sample in case the mothers want to leave the study, the sample milk is
spoiled or there are losses during the analysis.
2.3.4. Randomization Randomization will not be possible in the study. 2.4. Data Collection
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.
Collection of breast milk 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.
Collected breast milk samples will be frozen at -180C within two hours. It will be allowed to
dissolve by keeping it at +40C 48 hours before the analysis. Breast milk samples, which are
heated up to 400C in a water bath, will be homogenized by Miris Ultrasonic Homogenizer for 5
seconds just before analysis. Breast milk samples will be analyzed with Miris®️ HMA, and
protein, fat, carbohydrate and energy values will be determined. Miris®️ HMA (Uppsala,
Sweden) is certified by the International Standards Organization (ISO) 9622: 1999. The
device, which has different filters for special milk components, uses four different
wavebands for fat, protein and lactose determination. Miris®️ HMA device consists of a
cuvette and auxiliary equipment. The so-called cuvette is a mid-infrared measuring cell with
an inlet and an outlet. Breast milk is injected through the vestibule, passing through two
CaF2 windows divided by a spacer (50 μm). On one side of the windows is a source of infrared
radiation (emitter) and on the other side there is a four-channel detector that receives the
radiation transmitted through the liquid. The filters in the detector are chosen to absorb
mid-infrared radiation associated with fat, protein and carbohydrate. The fourth filter acts
as a reference filter. Radiation from the infrared source passes through the Transparent
cuvette with the liquid sample, assessing the amounts of radiation absorbed by specific
functional groups of fat, protein and carbohydrate, respectively. The quantitative
determination of fat, protein and carbohydrate absorbed in direct proportion to the
concentration is made according to Beer's law. Each macronutrient composition is calculated
by Miris®️ HMA in g per 100 ml. Fat molecules are determined by ester bonds to the carbonyl
groups of glycerides, and protein molecules are determined by the infrared method with the
second amide group of peptide bonds. The lactose content is analyzed by lactose and hydroxyl
groups of mono/oligosaccharides, and the total energy is determined by calculating the
measurement results. The pH measurement will be measured with the MW102, Milwaukee®
instrument.
2.4.1. Data Collection Tools 'Conformity to Criteria Form' (Appendix-1), Introductory
Information Form (Appendix-2) and 'Breast Milk Biochemical Analysis Form' (Appendix-3) will
be used in collecting research data.
2.4.1.1. Conformity to Criteria Form (Annex-1) This form includes a checklist of inclusion
criteria. 2.4.1.2. Introductory Information Form (Appendix -2) This form, which was developed
by the researcher using the literature, has 5, which determines the socio-demographic
characteristics of mothers (age, education level, income level, occupation), 6 that
determines their obstetric characteristics (number of pregnancy, gestational week, birth),
and 1 is about the baby and breastfeeding, a total of 12 forms. consists of questions.
2.4.1.3. Breast Milk Biochemical Analysis Form (Appendix-3) Developed by researchers. In the
evaluation of breast milk content, Ph, fat, carbohydrate, protein and energy values, which
are possible to change with the milking method, will be written on the form according to the
results of the analysis.
2.5. Evaluation of Data The data obtained in the research will be evaluated with the SPSS
(Statistical Package of Social Sciences) 22.0 package program. The homogeneity of the
variances in both groups will be checked with the Levene test, and the normality with the
Shaphiro Wilk test. If the variances are homogeneous and normally distributed, T-test will be
used for independent groups from parametric tests, and if the variances are not homogeneous
and do not show normal distribution, the Mann Whitney-U test will be used. 0.05 will be used
as the level of significance and it will be stated that there is a significant relationship
in case of p<0.05, and that there is no significant relationship in the case of p>0.05. In
order to determine the effect of mediator variables on breast milk, mediator and moderator
variable analyzes will be performed.
2.6. Ethical Aspect of Research The application will be started after the necessary
permissions from the institution where the research will be conducted, the ethics committee
and written consent from the mothers are obtained. Mothers can opt out of the study whenever
they want. No payment will be made to mothers for participating in the study.
