Mother-Infant InteractionNCT06096961
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment
A study testing Baby smell in people with Mother-Infant Interaction and Premature Birth, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this [type of study: randomized controlled clinical trial] is to [determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol level and mother-infant attachment.] in [mothers of premature babies]. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother-Infant Interaction, Premature Birth
- What is being tested?
- Baby smell
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Apr 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother's acceptance of the application
- Ability to communicate with the mother (being literate, speaking Turkish, etc.)
- Gestational week being 34 weeks or less
- The newborn is in the NICU
Who cannot join
- The newborn's gestational age is over 34 weeks
- The mother is breastfeeding her baby
- Being a smoker (Ahmed et al. 2019)
- The mother is unable to express milk due to a serious chronic disease or pregnancy complication.
- The mother has a breast problem that may affect milk expression (cracked, mastitis, collapse, etc.).
- If the mother uses milk-boosting drinks or food
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, 26000
ÖYKÜ BALİ BİLGİ, +905074160813, oykubali7@gmail.com
About this study
Official title: The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment: A Randomized Controlled Study
The goal of this [type of study: randomized controlled clinical trial] is to [determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol level and mother-infant attachment.] in [mothers of premature babies]. The main question[s] it aims to answer are:
- [Hypothesis 1: There is a difference in the amount of milk of the mother.]
- [Hypothesis 2: There is a difference in the level of cortisol in the mother's saliva.]
- [Hypothesis 3: There is a difference in terms of mother-baby attachment level.] Participants will [Participants will express milk and record the amount of milk.].
If there is a comparison group: Researchers will compare [control and experimental groups] to see if [difference in amount of milk, cortisol level, baby attachment].
Read the detailed description
The study was planned as a randomized controlled study to determine the effect of applying the scent of non-breastfeedable premature newborns to the mother on the mother's milk quantity, salivary cortisol level and mother-baby bonding. The study is planned to be conducted with the mothers of premature infants whose babies are hospitalized in the Neonatal Intensive Care Unit of Bursa City Hospital. There will be two groups in the study: study and control group. For each group, 30 mothers will be included in the study. The study will continue for four days. The mothers in the experimental group will be given the gowns that their babies wear for 12 hours and they will be asked to smell these gowns during the milking process. On the 1st day, mothers in both groups will be trained on expressing and storing breast milk (frequency of expressing milk, appropriate speed of the pump, milk storage bags, room temperature, storage times in the refrigerator and freezer). All mothers will be ensured to express their milk with the same milk pumps. Mothers will be provided with a syringe to measure their milk. The mothers will be asked to express their milk at three-hour intervals and record the amount measured. Mothers in the experimental group will be asked to smell their babies' scented clothes during the milking process. A sample will be taken from the mothers to look at the cortisol level in saliva. Data collection forms will be filled in. On the 2nd and 3rd day, mothers will be asked to express their milk at three-hour intervals and record the amount they measured on the mother follow-up form. The mothers in the experimental group will be asked to smell their babies' smelly clothes during the milking process. On the 4th day, mothers will be asked to express their milk at three-hour intervals and record the amount they measured on the mother follow-up form. The mothers in the experimental group will be asked to smell their babies' scented clothes during the milking process. The mothers will be sampled again to check the cortisol level in saliva. Mother-infant attachment scale will be applied.
- Conditions
- Mother-Infant Interaction, Premature Birth
- Being tested
- Baby smell
- Keywords
- mother milk, stress, mother baby bonding, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby smellBehavioural
Mothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process.
| Study group | Role | What they receive |
|---|---|---|
| Mothers using baby scent | Experimental | Mothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process. The work will continue for four days. Saliva cortisol test and mother-infant attachment scale will be applied on the first day and the last day. Receives: Behavioral: Baby smell |
| Mothers who do not use baby scent | No intervention | Mothers in the control group will express milk without any intervention. The works will continue for 4 days. Saliva cortisol test and mother-baby attachment scale will be applied on the first day and the last day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of breast milk
Measured: Mothers participating in the study will express their milk every three hours for four days and record the amount of milk.
Secondary outcomes (2)
mother baby attachment scale
This scale, which can be applied from the first day after birth and shows the relationship between the mother's mood and the bond established, allows the mother to express the feelings she feels towards her baby with a single word. The scale, whose original name is "Mother-to-Infant Bonding Scale", was developed by Taylor et al. in 2005. It was adapted into Turkish by Aydemir and Alparslan (2008). The scale is a 4-point Likert type and consists of eight items. Responses consist of four options and are scored between 0 and 3. Since they express positive emotion, the first, fourth and sixth items are scored as 0, 1, 2, 3, and since they express negative emotion, the second, third, fifth, seventh and eighth items are scored as 3, 2, 1, 0. The lowest score that can be obtained is 0, the highest score is 24.
Measured: The mother-infant attachment scale will be applied to the mothers participating in the study on the first and fourth day of the study.
salivary cortisol level
Measured: Saliva cortisol test will be applied to the mothers participating in the study on the first and fourth day of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Mother-Infant InteractionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in the study: experimental and control groups. Mothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process. The work will continue for four days. Mothers in the intervention group will smell their baby's scented diapers, and mothers in the control group will express their milk without any intervention and record the amount.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öykü Bali, Eskisehir Osmangazi University
- Investigators
- AYFER ACIKGOZ, Study director, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096961
- Sponsor's protocol ID
- OYKUCALISMA
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akkoca Z, Yigit D, Acikgoz A. The Effect of Neonates' Exposure to Their Mother's Scent on Weight Gain: A Randomized Controlled Study. Breastfeed Med. 2022 Jan;17(1):79-84. doi: 10.1089/bfm.2021.0274. Epub 2021 Dec 22.
PubMed 34939823Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.
PubMed 33085532Chrustek A, Dombrowska-Pali A, Olszewska-Slonina D. Analysis of the composition and antioxidant status of breast milk in women giving birth prematurely and on time. PLoS One. 2021 Jul 23;16(7):e0255252. doi: 10.1371/journal.pone.0255252. eCollection 2021.
PubMed 34297788Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.
PubMed 26495909Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.
PubMed 26023551Miller J, Tonkin E, Damarell RA, McPhee AJ, Suganuma M, Suganuma H, Middleton PF, Makrides M, Collins CT. A Systematic Review and Meta-Analysis of Human Milk Feeding and Morbidity in Very Low Birth Weight Infants. Nutrients. 2018 May 31;10(6):707. doi: 10.3390/nu10060707.
PubMed 29857555Montirosso R, Provenzi L, Calciolari G, Borgatti R; NEO-ACQUA Study Group. Measuring maternal stress and perceived support in 25 Italian NICUs. Acta Paediatr. 2012 Feb;101(2):136-42. doi: 10.1111/j.1651-2227.2011.02440.x. Epub 2011 Sep 14.
PubMed 21827551Neu M, Hazel NA, Robinson J, Schmiege SJ, Laudenslager M. Effect of holding on co-regulation in preterm infants: a randomized controlled trial. Early Hum Dev. 2014 Mar;90(3):141-7. doi: 10.1016/j.earlhumdev.2014.01.008. Epub 2014 Jan 27.
PubMed 24480604Rojas MA, Kaplan M, Quevedo M, Sherwonit E, Foster L, Ehrenkranz RA, Mayes L. Somatic growth of preterm infants during skin-to-skin care versus traditional holding: a randomized, controlled trial. J Dev Behav Pediatr. 2003 Jun;24(3):163-8. doi: 10.1097/00004703-200306000-00006.
PubMed 12806228Tasci B, Kuzlu Ayyildiz T. The Calming Effect of Maternal Breast Milk Odor on Term Infant: A Randomized Controlled Trial. Breastfeed Med. 2020 Nov;15(11):724-730. doi: 10.1089/bfm.2020.0116. Epub 2020 Oct 29.
PubMed 33121256Taylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4.
PubMed 15868385Trend S, Strunk T, Lloyd ML, Kok CH, Metcalfe J, Geddes DT, Lai CT, Richmond P, Doherty DA, Simmer K, Currie A. Levels of innate immune factors in preterm and term mothers' breast milk during the 1st month postpartum. Br J Nutr. 2016 Apr 14;115(7):1178-93. doi: 10.1017/S0007114516000234. Epub 2016 Feb 19.
PubMed 26891901Ahmed, F., Jean-Baptiste, F., Thompson, A., Nwokorie, U., Nya, G. E., & Bassey, G. O. . Effects of maternal tobacco smoking on breast milk composition and infant development: a literature review. J Bacteriol Mycol Open Access. 2019; 7(5): 107-110.
Aydemir Karakulak, H, Alparslan, Ö. Anne-bebek bağlanma ölçeğinin türk toplumuna uyarlanması: Aydın örneği . Çağdaş Tıp Dergisi. 2016; 6 (3) : 188-199 .
Dabas S, Joshi P, Agarwal R, Yadav RK, & Kachhawa G. Impact of audio assisted relaxation technique on stress, anxiety and milk output among postpartum mothers of hospitalized neonates: A randomized controlled trial. Journal of Neonatal Nursing. 2019; 25(4): 200-204.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06096961
- Acronym / sponsor ID
- OYKUCALISMA
- Conditions
- Mother-Infant Interaction, Premature Birth
- Keywords
- mother milk, stress, mother baby bonding, premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 24 Oct 2023 (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 goal of this [type of study: randomized controlled clinical trial] is to [determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol level and mother-infant attachment.] in [mothers of premature babies]. The main question[s] it aims to answer are:
- [Hypothesis 1: There is a difference in the amount of milk of the mother.]
- [Hypothesis 2: There is a difference in the level of cortisol in the mother's saliva.]
- [Hypothesis 3: There is a difference in terms of mother-baby attachment level.] Participants will [Participants will express milk and record the amount of milk.].
If there is a comparison group: Researchers will compare [control and experimental groups] to see if [difference in amount of milk, cortisol level, baby attachment].
Detailed description
The study was planned as a randomized controlled study to determine the effect of applying the scent of non-breastfeedable premature newborns to the mother on the mother's milk quantity, salivary cortisol level and mother-baby bonding. The study is planned to be conducted with the mothers of premature infants whose babies are hospitalized in the Neonatal Intensive Care Unit of Bursa City Hospital. There will be two groups in the study: study and control group. For each group, 30 mothers will be included in the study. The study will continue for four days. The mothers in the experimental group will be given the gowns that their babies wear for 12 hours and they will be asked to smell these gowns during the milking process. On the 1st day, mothers in both groups will be trained on expressing and storing breast milk (frequency of expressing milk, appropriate speed of the pump, milk storage bags, room temperature, storage times in the refrigerator and freezer). All mothers will be ensured to express their milk with the same milk pumps. Mothers will be provided with a syringe to measure their milk. The mothers will be asked to express their milk at three-hour intervals and record the amount measured. Mothers in the experimental group will be asked to smell their babies' scented clothes during the milking process. A sample will be taken from the mothers to look at the cortisol level in saliva. Data collection forms will be filled in. On the 2nd and 3rd day, mothers will be asked to express their milk at three-hour intervals and record the amount they measured on the mother follow-up form. The mothers in the experimental group will be asked to smell their babies' smelly clothes during the milking process. On the 4th day, mothers will be asked to express their milk at three-hour intervals and record the amount they measured on the mother follow-up form. The mothers in the experimental group will be asked to smell their babies' scented clothes during the milking process. The mothers will be sampled again to check the cortisol level in saliva. Mother-infant attachment scale will be applied.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- There are two groups in the study: experimental and control groups. Mothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process. The work will continue for four days. Mothers in the intervention group will smell their baby's scented diapers, and mothers in the control group will express their milk without any intervention and record the amount.
| Arm | Type | Receives |
|---|---|---|
| Mothers using baby scent | Experimental | Behavioral: Baby smellMothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process. The work will continue for four days. Saliva cortisol test and mother-infant attachment scale will be applied on the first day and the last day. |
| Mothers who do not use baby scent | No intervention | –Mothers in the control group will express milk without any intervention. The works will continue for 4 days. Saliva cortisol test and mother-baby attachment scale will be applied on the first day and the last day. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mother's acceptance of the application
- Ability to communicate with the mother (being literate, speaking Turkish, etc.)
- Gestational week being 34 weeks or less
- The newborn is in the NICU
Key exclusion criteria (6 listed)
- The newborn's gestational age is over 34 weeks
- The mother is breastfeeding her baby
- Being a smoker (Ahmed et al. 2019)
- The mother is unable to express milk due to a serious chronic disease or pregnancy complication.
- The mother has a breast problem that may affect milk expression (cracked, mastitis, collapse, etc.).
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 |
|---|---|---|
| Baby smellMothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process. | Behavioural | Mothers using baby scent |
Primary outcome
amount of breast milk
Time frame: Mothers participating in the study will express their milk every three hours for four days and record the amount of milk.
2 secondary outcomes
mother baby attachment scale
Time frame: The mother-infant attachment scale will be applied to the mothers participating in the study on the first and fourth day of the study.
salivary cortisol level
Time frame: Saliva cortisol test will be applied to the mothers participating in the study on the first and fourth day of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 34939823Akkoca Z, Yigit D, Acikgoz A. The Effect of Neonates' Exposure to Their Mother's Scent on Weight Gain: A Randomized Controlled Study. Breastfeed Med. 2022 Jan;17(1):79-84. doi: 10.1089/bfm.2021.0274. Epub 2021 Dec 22.
- Background: PubMed 33085532Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.
- Background: PubMed 34297788Chrustek A, Dombrowska-Pali A, Olszewska-Slonina D. Analysis of the composition and antioxidant status of breast milk in women giving birth prematurely and on time. PLoS One. 2021 Jul 23;16(7):e0255252. doi: 10.1371/journal.pone.0255252. eCollection 2021.
- Background: PubMed 26495909Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.
- Background: PubMed 26023551Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.
- Background: PubMed 29857555Miller J, Tonkin E, Damarell RA, McPhee AJ, Suganuma M, Suganuma H, Middleton PF, Makrides M, Collins CT. A Systematic Review and Meta-Analysis of Human Milk Feeding and Morbidity in Very Low Birth Weight Infants. Nutrients. 2018 May 31;10(6):707. doi: 10.3390/nu10060707.
- Background: PubMed 21827551Montirosso R, Provenzi L, Calciolari G, Borgatti R; NEO-ACQUA Study Group. Measuring maternal stress and perceived support in 25 Italian NICUs. Acta Paediatr. 2012 Feb;101(2):136-42. doi: 10.1111/j.1651-2227.2011.02440.x. Epub 2011 Sep 14.
- Background: PubMed 24480604Neu M, Hazel NA, Robinson J, Schmiege SJ, Laudenslager M. Effect of holding on co-regulation in preterm infants: a randomized controlled trial. Early Hum Dev. 2014 Mar;90(3):141-7. doi: 10.1016/j.earlhumdev.2014.01.008. Epub 2014 Jan 27.
- Background: PubMed 12806228Rojas MA, Kaplan M, Quevedo M, Sherwonit E, Foster L, Ehrenkranz RA, Mayes L. Somatic growth of preterm infants during skin-to-skin care versus traditional holding: a randomized, controlled trial. J Dev Behav Pediatr. 2003 Jun;24(3):163-8. doi: 10.1097/00004703-200306000-00006.
- Background: PubMed 33121256Tasci B, Kuzlu Ayyildiz T. The Calming Effect of Maternal Breast Milk Odor on Term Infant: A Randomized Controlled Trial. Breastfeed Med. 2020 Nov;15(11):724-730. doi: 10.1089/bfm.2020.0116. Epub 2020 Oct 29.
- Background: PubMed 15868385Taylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4.
- Background: PubMed 26891901Trend S, Strunk T, Lloyd ML, Kok CH, Metcalfe J, Geddes DT, Lai CT, Richmond P, Doherty DA, Simmer K, Currie A. Levels of innate immune factors in preterm and term mothers' breast milk during the 1st month postpartum. Br J Nutr. 2016 Apr 14;115(7):1178-93. doi: 10.1017/S0007114516000234. Epub 2016 Feb 19.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
AYFER ACIKGOZ study director
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby smell in people with Mother-Infant Interaction and Premature Birth, run by Eskisehir Osmangazi 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OYKU BALI BILGI (+905074160813, oykubali7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of breast milk (time frame: Mothers participating in the study will express their milk every three hours for four days and record the amount of milk.). 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 NCT06096961, which also lists 21 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 24 Oct 2023.