BreastfeedingNCT04619459
The Effect of Kangaroo Mother Care Applied to the Healthy Newborns on Breastfeeding
A study testing Kangaroo Mother Care (KMC) in people with Breastfeeding and Kangaroo Mother Care, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effect of kangaroo mother care (KMC) applied to the healthy newborns in the early postpartum period on breastfeeding. The results of the study are expected to contribute to promoting the practice of KMC in an effort to encourage breastfeeding not only in Turkey's hospitals but also in… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Kangaroo Mother Care, Breastfeeding, Exclusive
- What is being tested?
- Kangaroo Mother Care (KMC)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2016to 30 Aug 2016
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy mothers
- The women were between the ages 18-42,
- Had delivered normal vaginal birth
- Between gestational weeks 38-40
- Consented to be a part of the study
- Newborn being at term (in the 38th-42nd week), with a birthweight of 2500-4000 gr.
Show all 9Show fewer
- No serious case of asphyxiation in the newborn,
- APGAR score of at least 7 at Minute 1 and Minute 5,
- No health problem in the newborn to prevent it from breastfeeding
Who cannot join
- Instrumental vaginal deliveries
- Cesarean deliveries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kangaroo Mother Care Applied to the Healthy Newborns in the Early Postpartum Period on Breastfeeding: Randomized Controlled Study
This study aims to determine the effect of kangaroo mother care (KMC) applied to the healthy newborns in the early postpartum period on breastfeeding.
The results of the study are expected to contribute to promoting the practice of KMC in an effort to encourage breastfeeding not only in Turkey's hospitals but also in other developing countries where practices that negatively affect breastfeeding are prevalent.
The hypotheses of the study were determined as: Infants administered KMC start to breastfeed sooner (H1), breastfeed more frequently (H2), breastfeed for longer periods (H3), are more successful at breastfeeding (H4) than infants receiving standard postpartum care (SPC).
Read the detailed description
Setting: The study was conducted over the period June 1 - August 25, 2016 as randomized controlled experimental research at a Training and Research Hospital in Istanbul, Turkey.
Participants: The participants were 112 healthy mothers and their babies; the women were between the ages 18-42, had delivered normal vaginal birth between gestational weeks 38-40, met the sample inclusion criteria and consented to be a part of the study. Instrumental vaginal deliveries were excluded from this study.
The sample selection criteria were determined as: normal delivery, healthy mother and child, newborn being at term (in the 38th-42nd week), with a birthweight of 2500-4000 gr. The inclusion criteria were determined as: no serious case of asphyxiation in the newborn, an APGAR score of at least 7 at Minute 1 and Minute 5, no health problem in the newborn to prevent it from breastfeeding (e.g., cleft palate, harelip, esophageal atresia).
Sample and randomization: The researcher met with the mothers who fulfilled the selection criteria prior to the birth and briefly informed them of the scope and content of the study, asking them if they wished to participate. At this stage, participation was proposed to 119 mothers. Of these, 112 mothers and their babies were randomized into two groups with 56 in the study group (KMC) and 56 in the control group (SPC). A computerized randomization method was used for implementing the random selection. The newborns that exhibited a health issue following the birth were excluded from the study. In their place, the same randomization method was used until 56 cases were defined. The number of newborns held outside the scope of the study after birth was 5 in the study group and 2 in the control group.
Power analysis was performed using the G*Power (v3.1.9) program in order to determine the number in the sample. Sample size was determined on the basis of the infants' breastfeeding scores obtained on LATCH. It was foreseen that a unit of difference in LATCH scores between groups would be clinically significant. In a study by Yenal et al., when the LATCH mean score and standard deviation were accepted as a reference for control group data, effect size was calculated as d=0.566. It was calculated that at least 51 individuals would have to be included in the groups, a total of 102, to realize the effect level of α=0.05 at a power of 80%. Taking into consideration possible losses, it was decided that the groups would each comprise at least 56, meaning a total of 112 individuals.
Data collection: The study data were collected in line with the literature using the Data Collection Form developed by researchers. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al.
Consent: Permission for conduct of the study was obtained from the hospital and the ethics committee (10840098-604.01.01-E.1108). At the same time, prior to the start of the study, the mothers were informed about the purpose and methodology of the research and the mothers agreeing to participate were asked to sign a written Subject Informed Consent Form.
Data analysis: The NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah, USA) program was used in the statistical analysis. In the evaluation of the study data, besides descriptive statistical methods (means, standard deviation, median, frequency and percentages), the Shapiro-Wilk test and box plot graphs were employed in testing normality. The Independent Samples T Test was used to analyze two groups of quantitative data displaying normal distribution such as the newborns' weight, height, head circumference, number of breastfeedings received, mother's age. The Mann-Whitney U test was used in the case of variables not showing normal distribution, such as the newborns' APGAR scores at Minutes 1 and 5, the first interaction of the mother with her infant, the first time of breastfeeding, the number of breastfeedings in the first 3 hours and their duration. The comparison of qualitative data such as the infants' gender, the mother's educational status, the status of being breastfed in the first half-hour and hour was undertaken with Pearson's Chi Square while the Fisher-Freeman-Halton test was used to compare the mothers' eagerness to breastfeed. The results were analyzed at a confidence interval of 95% with significance expressed at a level of p<0.05.
- Being tested
- Kangaroo Mother Care (KMC)
- Keywords
- Kangaroo Mother Care, Breastfeeding, Postpartum Period, Term Newborn, Midwifery
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother Care (KMC)Other
Kangaroo mother care is a method of care of infants. The method involves infants being carried, usually by the mother, with skin-to-skin contact. Kangaroo mother care (KMC). early after delivery have better success at breastfeeding and achieve this success sooner. In this method The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. The KMC session was continued for 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Newborns receiving Kangaroo Mother Care (KMC) | Experimental | The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. At Minute 5, the newborns' Apgar scores were assessed and recorded during KMC. The newborn's examination and injections (Hepatitis-B and K vit) were postponed until the first breastfeeding took place. A pediatrician performed a detailed examination of the newborns under the radiant infant warmer after the first breastfeeding. Following the examination, the newborn was positioned on the mother's breast for KMC. During this KMC, the newborn was administered 1 mg K vitamin in the right leg and 0.5 ml Hepatitis-B vaccine in the left leg via intramuscular injections. The KMC session was continued for 3 hours. Care attempt of mothers such as episiotomy repair was taken that the position of KMC. Receives: Other: Kangaroo Mother Care (KMC) |
| Newborns receiving standard postpartum care (SPC): | No intervention | He received the standard care of the hospital. KMC not applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Assessment Tool
The infants' suckling skills were assessed with this scale. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al. and for which the validity and reliability testing of the Turkish version had been conducted by Yenal and Okumuş in 2003. The LATCH instrument comprises five parameters (Latch on breast, Audible swallowing, Type of nipple, Comfort breast/nipple, Hold/help) on which each item is assessed on the basis of 0-2. The highest possible score on the scale is 10; the lowest is 0.
Measured: It was used in both groups before the first breastfeeding.
LATCH Breastfeeding Assessment Tool
The infants' suckling skills were assessed with this scale. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al. and for which the validity and reliability testing of the Turkish version had been conducted by Yenal and Okumuş in 2003. The LATCH instrument comprises five parameters (Latch on breast, Audible swallowing, Type of nipple, Comfort breast/nipple, Hold/help) on which each item is assessed on the basis of 0-2. The highest possible score on the scale is 10; the lowest is 0.
Measured: After 24 hours the sucking ability of both groups was evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jun 2016
- Primary completion25 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sevda KORKUT ÖKSÜZ, Ahi Evran University Education and Research Hospital
- Investigators
- Sevda K Öksüz, R.A, Principal investigator, Ahi Evran University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619459
- Sponsor's protocol ID
- AhiEvranEDU
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I did not find it appropriate to share it.
Publications
Inal S, Aydin Y, Canbulat N. Factors associated with breastfeeding initiation time in a baby-friendly hospital in Istanbul. Appl Nurs Res. 2016 Nov;32:26-29. doi: 10.1016/j.apnr.2016.03.008. Epub 2016 Apr 1.
PubMed 27969039Thukral A, Sankar MJ, Agarwal R, Gupta N, Deorari AK, Paul VK. Early skin-to-skin contact and breast-feeding behavior in term neonates: a randomized controlled trial. Neonatology. 2012;102(2):114-9. doi: 10.1159/000337839. Epub 2012 Jun 14.
PubMed 22699241Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Schiff DM, Wachman EM, Philipp B, Joseph K, Shrestha H, Taveras EM, Parker MGK. Examination of Hospital, Maternal, and Infant Characteristics Associated with Breastfeeding Initiation and Continuation Among Opioid-Exposed Mother-Infant Dyads. Breastfeed Med. 2018 May;13(4):266-274. doi: 10.1089/bfm.2017.0172. Epub 2018 Apr 9.
PubMed 29630387Aghdas K, Talat K, Sepideh B. Effect of immediate and continuous mother-infant skin-to-skin contact on breastfeeding self-efficacy of primiparous women: a randomised control trial. Women Birth. 2014 Mar;27(1):37-40. doi: 10.1016/j.wombi.2013.09.004. Epub 2013 Nov 9.
PubMed 24216342Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
PubMed 27885658Oksuz SK, Inal S. The effect of kangaroo mother care applied to the healthy newborns in the early postpartum period on breastfeeding: A randomized controlled trial. J Pak Med Assoc. 2021 Sep;71(9):2124-2129. doi: 10.47391/JPMA.376.
PubMed 34580499
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Mother Care Applied to the Healthy Newborns in the Early Postpartum Period on Breastfeeding: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04619459
- Acronym / sponsor ID
- AhiEvranEDU
- Keywords
- Kangaroo Mother Care, Breastfeeding, Postpartum Period, Term Newborn, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 25 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 6 Nov 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.
This study aims to determine the effect of kangaroo mother care (KMC) applied to the healthy newborns in the early postpartum period on breastfeeding.
The results of the study are expected to contribute to promoting the practice of KMC in an effort to encourage breastfeeding not only in Turkey's hospitals but also in other developing countries where practices that negatively affect breastfeeding are prevalent.
The hypotheses of the study were determined as: Infants administered KMC start to breastfeed sooner (H1), breastfeed more frequently (H2), breastfeed for longer periods (H3), are more successful at breastfeeding (H4) than infants receiving standard postpartum care (SPC).
Detailed description
Setting: The study was conducted over the period June 1 - August 25, 2016 as randomized controlled experimental research at a Training and Research Hospital in Istanbul, Turkey.
Participants: The participants were 112 healthy mothers and their babies; the women were between the ages 18-42, had delivered normal vaginal birth between gestational weeks 38-40, met the sample inclusion criteria and consented to be a part of the study. Instrumental vaginal deliveries were excluded from this study.
The sample selection criteria were determined as: normal delivery, healthy mother and child, newborn being at term (in the 38th-42nd week), with a birthweight of 2500-4000 gr. The inclusion criteria were determined as: no serious case of asphyxiation in the newborn, an APGAR score of at least 7 at Minute 1 and Minute 5, no health problem in the newborn to prevent it from breastfeeding (e.g., cleft palate, harelip, esophageal atresia).
Sample and randomization: The researcher met with the mothers who fulfilled the selection criteria prior to the birth and briefly informed them of the scope and content of the study, asking them if they wished to participate. At this stage, participation was proposed to 119 mothers. Of these, 112 mothers and their babies were randomized into two groups with 56 in the study group (KMC) and 56 in the control group (SPC). A computerized randomization method was used for implementing the random selection. The newborns that exhibited a health issue following the birth were excluded from the study. In their place, the same randomization method was used until 56 cases were defined. The number of newborns held outside the scope of the study after birth was 5 in the study group and 2 in the control group.
Power analysis was performed using the G*Power (v3.1.9) program in order to determine the number in the sample. Sample size was determined on the basis of the infants' breastfeeding scores obtained on LATCH. It was foreseen that a unit of difference in LATCH scores between groups would be clinically significant. In a study by Yenal et al., when the LATCH mean score and standard deviation were accepted as a reference for control group data, effect size was calculated as d=0.566. It was calculated that at least 51 individuals would have to be included in the groups, a total of 102, to realize the effect level of α=0.05 at a power of 80%. Taking into consideration possible losses, it was decided that the groups would each comprise at least 56, meaning a total of 112 individuals.
Data collection: The study data were collected in line with the literature using the Data Collection Form developed by researchers. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al.
Consent: Permission for conduct of the study was obtained from the hospital and the ethics committee (10840098-604.01.01-E.1108). At the same time, prior to the start of the study, the mothers were informed about the purpose and methodology of the research and the mothers agreeing to participate were asked to sign a written Subject Informed Consent Form.
Data analysis: The NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah, USA) program was used in the statistical analysis. In the evaluation of the study data, besides descriptive statistical methods (means, standard deviation, median, frequency and percentages), the Shapiro-Wilk test and box plot graphs were employed in testing normality. The Independent Samples T Test was used to analyze two groups of quantitative data displaying normal distribution such as the newborns' weight, height, head circumference, number of breastfeedings received, mother's age. The Mann-Whitney U test was used in the case of variables not showing normal distribution, such as the newborns' APGAR scores at Minutes 1 and 5, the first interaction of the mother with her infant, the first time of breastfeeding, the number of breastfeedings in the first 3 hours and their duration. The comparison of qualitative data such as the infants' gender, the mother's educational status, the status of being breastfed in the first half-hour and hour was undertaken with Pearson's Chi Square while the Fisher-Freeman-Halton test was used to compare the mothers' eagerness to breastfeed. The results were analyzed at a confidence interval of 95% with significance expressed at a level of p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Newborns receiving Kangaroo Mother Care (KMC) | Experimental | Other: Kangaroo Mother Care (KMC)The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. At Minute 5, the newborns' Apgar scores were assessed and recorded during KMC. The newborn's examination and injections (Hepatitis-B and K vit) were postponed until the first breastfeeding took place. A pediatrician performed a detailed examination of the newborns under the radiant infant warmer after the first breastfeeding. Following the examination, the newborn was positioned on the mother's breast for KMC. During this KMC, the newborn was administered 1 mg K vitamin in the right leg and 0.5 ml Hepatitis-B vaccine in the left leg via intramuscular injections. The KMC session was continued for 3 hours. Care attempt of mothers such as episiotomy repair was taken that the position of KMC. |
| Newborns receiving standard postpartum care (SPC): | No intervention | –He received the standard care of the hospital. KMC not applied. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy mothers
- The women were between the ages 18-42,
- Had delivered normal vaginal birth
- Between gestational weeks 38-40
- Consented to be a part of the study
Key exclusion criteria (2 listed)
- Instrumental vaginal deliveries
- Cesarean deliveries
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 |
|---|---|---|
| Kangaroo Mother Care (KMC)Kangaroo mother care is a method of care of infants. The method involves infants being carried, usually by the mother, with skin-to-skin contact. Kangaroo mother care (KMC). early after delivery have better success at breastfeeding and achieve this success sooner. In this method The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. The KMC session was continued for 3 hours. | Other | Newborns receiving Kangaroo Mother Care (KMC) |
Primary outcome
LATCH Breastfeeding Assessment Tool
Time frame: It was used in both groups before the first breastfeeding.
The infants' suckling skills were assessed with this scale. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al. and for which the validity and reliability testing of the Turkish version had been conducted by Yenal and Okumuş in 2003. The LATCH instrument comprises five parameters (Latch on breast, Audible swallowing, Type of nipple, Comfort breast/nipple, Hold/help) on which each item is assessed on the basis of 0-2. The highest possible score on the scale is 10; the lowest is 0.
LATCH Breastfeeding Assessment Tool
Time frame: After 24 hours the sucking ability of both groups was evaluated.
The infants' suckling skills were assessed with this scale. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al. and for which the validity and reliability testing of the Turkish version had been conducted by Yenal and Okumuş in 2003. The LATCH instrument comprises five parameters (Latch on breast, Audible swallowing, Type of nipple, Comfort breast/nipple, Hold/help) on which each item is assessed on the basis of 0-2. The highest possible score on the scale is 10; the lowest is 0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 27969039Inal S, Aydin Y, Canbulat N. Factors associated with breastfeeding initiation time in a baby-friendly hospital in Istanbul. Appl Nurs Res. 2016 Nov;32:26-29. doi: 10.1016/j.apnr.2016.03.008. Epub 2016 Apr 1.
- Background: PubMed 22699241Thukral A, Sankar MJ, Agarwal R, Gupta N, Deorari AK, Paul VK. Early skin-to-skin contact and breast-feeding behavior in term neonates: a randomized controlled trial. Neonatology. 2012;102(2):114-9. doi: 10.1159/000337839. Epub 2012 Jun 14.
- Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Background: PubMed 29630387Schiff DM, Wachman EM, Philipp B, Joseph K, Shrestha H, Taveras EM, Parker MGK. Examination of Hospital, Maternal, and Infant Characteristics Associated with Breastfeeding Initiation and Continuation Among Opioid-Exposed Mother-Infant Dyads. Breastfeed Med. 2018 May;13(4):266-274. doi: 10.1089/bfm.2017.0172. Epub 2018 Apr 9.
- Background: PubMed 24216342Aghdas K, Talat K, Sepideh B. Effect of immediate and continuous mother-infant skin-to-skin contact on breastfeeding self-efficacy of primiparous women: a randomised control trial. Women Birth. 2014 Mar;27(1):37-40. doi: 10.1016/j.wombi.2013.09.004. Epub 2013 Nov 9.
- Background: PubMed 27885658Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
- Derived from this study: PubMed 34580499Oksuz SK, Inal S. The effect of kangaroo mother care applied to the healthy newborns in the early postpartum period on breastfeeding: A randomized controlled trial. J Pak Med Assoc. 2021 Sep;71(9):2124-2129. doi: 10.47391/JPMA.376.
- Individual participant dataSharing planned: No. I did not find it appropriate to share it.
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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.
Sevda K Öksüz, R.A principal investigator
Ahi Evran University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Mother Care (KMC) in people with Breastfeeding and Kangaroo Mother Care, run by Ahi Evran University Education and Research Hospital 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 6 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LATCH Breastfeeding Assessment Tool (time frame: It was used in both groups before the first breastfeeding.). The study lists 2 primary outcomes in all. 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 NCT04619459, which also lists 7 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 6 Nov 2020.