Infant, NewbornNCT05001334
Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns
A study testing Kangaroo care training in people with Infant, Newborn and Weight Loss, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns. Read more about this study
- Who is it for?
- Ages Up to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Weight Loss
- What is being tested?
- Kangaroo care training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 31 Dec 2022
- 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 Up to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term babies born between 37-42 weeks of gestation
- Newborns born vaginally
- Newborns with developed sucking and swallowing reflexes
Who cannot join
- Newborns born with C-section
- Newborns in need of NICU care
- Preterm newborns (born <37 weeks of gestation)
- Newborns in need of oxygen
- Genetic or metabolic disease (of the baby) limiting breastfeeding
- HIV (+) mother
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- Mother having a chronic disease that will affect breastfeeding
- Mother using drugs that pass into the breastmilk and affect the baby
- Presence of a medical problem that will prevent the mother and baby from staying together
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa Florence Nightingale School of Nursing
Istanbul
Nuray Dilek, +905533919281, nevnuraydilek35@gmail.com
Nevin Hotun Sahin, Prof, +905337294337, nevinsah@istanbul.edu.tr
About this study
Official title: Evaluating the Efficiency of Kangaroo Care on Physiological Weight Loss in Term Newborns by Means of Number of Feedings, Number of Diapers and Periodic Weight Measurements
The aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns.
Read the detailed description
The data collection process continues in a randomized controlled experimental study conducted to determine the effect of kangaroo care on physiological weight loss in term newborns. In the calculation made for the determined effect size, 80% power, 5% margin of error and one-way statistical significance, the experimental group was planned as 51 and the control group as 51 newborns. In this reporting period, 25 newborns as the experimental group and 30 newborns as the control group were followed up and interviewed with the mother.
Mothers who meet the criteria to participate in the research are informed about the research in the delivery room or in the first hours of delivery. The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.
Breastfeeding of the mother, the number and frequency of bottle feeding, kangaroo care, diuresis, defecation numbers and weight are recorded by following up. Physiological weight losses are determined by comparing birth weight with daily weight losses.
A cotton kangaroo care blanket is given to every mother who agrees to participate in the study, so that mothers can care for their kangaroos comfortably and to continue kangaroo care at home. These covers, prepared for kangaroo care, increase the motivation of mothers to participate in the study. In order to facilitate the follow-up of diuresis and defecation numbers, the family is supported in the evaluation of diapers (number, weight).
- Conditions
- Infant, Newborn, Weight Loss
- Being tested
- Kangaroo care training
- Keywords
- term newborn, weight loss, kangaroo care
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo care trainingBehavioural
During perinatal period, mothers are given extra training (other than routine newborn care) about kangaroo care. Baby-mother diad is called for weight check-ups.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo care | Experimental | The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to. Receives: Behavioral: Kangaroo care training |
| Control group | No intervention | The mothers of the control group who accept to participate in the research are NOT given any extra training other than routine breastfeeding and care of a newborn. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological weight loss evaluation
Physiological weight loss of term newborns whose mothers are trained about and perform kangaroo care, is theorised to be less than those who receive standard newborn care information. Periodical weight measurements will be recorded. To evaluate feeding efficiency, number of feedings and kangaroo care periods, changed diaper numbers will be evaluated.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Nuray Dilek, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001334
- Sponsor's protocol ID
- Kanguru
- Status last verified
- Aug 2021
- First submitted
- 9 Jun 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If required participant information can be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficiency of Kangaroo Care on Physiological Weight Loss in Term Newborns by Means of Number of Feedings, Number of Diapers and Periodic Weight Measurements
- ClinicalTrials.gov ID
- NCT05001334
- Acronym / sponsor ID
- Kanguru
- Conditions
- Infant, Newborn, Weight Loss
- Keywords
- term newborn, weight loss, kangaroo care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Aug 2021 (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 aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns.
Detailed description
The data collection process continues in a randomized controlled experimental study conducted to determine the effect of kangaroo care on physiological weight loss in term newborns. In the calculation made for the determined effect size, 80% power, 5% margin of error and one-way statistical significance, the experimental group was planned as 51 and the control group as 51 newborns. In this reporting period, 25 newborns as the experimental group and 30 newborns as the control group were followed up and interviewed with the mother.
Mothers who meet the criteria to participate in the research are informed about the research in the delivery room or in the first hours of delivery. The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.
Breastfeeding of the mother, the number and frequency of bottle feeding, kangaroo care, diuresis, defecation numbers and weight are recorded by following up. Physiological weight losses are determined by comparing birth weight with daily weight losses.
A cotton kangaroo care blanket is given to every mother who agrees to participate in the study, so that mothers can care for their kangaroos comfortably and to continue kangaroo care at home. These covers, prepared for kangaroo care, increase the motivation of mothers to participate in the study. In order to facilitate the follow-up of diuresis and defecation numbers, the family is supported in the evaluation of diapers (number, weight).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo care | Experimental | Behavioral: Kangaroo care trainingThe mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to. |
| Control group | No intervention | –The mothers of the control group who accept to participate in the research are NOT given any extra training other than routine breastfeeding and care of a newborn. |
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term babies born between 37-42 weeks of gestation
- Newborns born vaginally
- Newborns with developed sucking and swallowing reflexes
Key exclusion criteria (9 listed)
- Newborns born with C-section
- Newborns in need of NICU care
- Preterm newborns (born <37 weeks of gestation)
- Newborns in need of oxygen
- Genetic or metabolic disease (of the baby) limiting breastfeeding
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 care trainingDuring perinatal period, mothers are given extra training (other than routine newborn care) about kangaroo care. Baby-mother diad is called for weight check-ups. | Behavioural | Kangaroo care |
Primary outcome
Physiological weight loss evaluation
Time frame: 1 week
Physiological weight loss of term newborns whose mothers are trained about and perform kangaroo care, is theorised to be less than those who receive standard newborn care information. Periodical weight measurements will be recorded. To evaluate feeding efficiency, number of feedings and kangaroo care periods, changed diaper numbers will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: Undecided. If required participant information can be shared
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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.
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 care training in people with Infant, Newborn and Weight Loss, run by Istanbul 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 3 inclusion and 9 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 11 Aug 2021. 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 Nuray Dilek (+905533919281, nevnuraydilek35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological weight loss evaluation (time frame: 1 week). 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 11 Aug 2021.