BreastfeedingNCT06028581
The Effect of Breastfeeding Support System
A study testing breastfeeding support system in people with Breastfeeding, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to determine the effect of breastfeeding support system applied in newborns on developmental findings and discharge time.The research was planned as an experimental study with experimental and control groups. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- breastfeeding support system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 Jul 2023
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
- Inclusion Criteria: Before age of 28 days
- Exclusion Criteria: After age of 29 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breastfeeding Support System in Newborns on Developmental Findings and Discharge Time
It is aimed to determine the effect of breastfeeding support system applied in newborns on developmental findings and discharge time.The research was planned as an experimental study with experimental and control groups. The population of the study consisted of babies who received care and treatment in Iğdır State Hospital Neonatal Intensive Care Clinic between February and June 2023. The sample of the study was calculated using the G*Power computer program. In the calculation made, it was found that a total of 70 children, 35 of each for the control and experimental groups, should be included. In this study, the experimental group consisted of 36 children and the control group consisted of 35 children. Children selected by simple random sampling method were divided into groups by randomization and which group would be the experimental group and which group would be the control group were determined by randomization. Masking was done during data collection and data analysis. The data is in the analysis stage.
Read the detailed description
Breast milk is a natural food with high bioavailability, easy to digest, which reduces the morbidity and mortality of the newborn, contains all the fluid, energy and nutrients necessary for physical, spiritual and mental development.Breastfeeding has a biological and emotional impact on mother and baby, has many immunological, psychological, social and economic benefits for both mother and baby, and is the best method for maternal health and healthy growth and development of infants.The bond between mother and baby after birth In the sensitive period in which successful breastfeeding will be established by establishing a new hospital, some babies need to be hospitalized in the neonatal intensive care unit (NICU) for various reasons. During hospitalization, mothers cannot be with their babies during all feedings and often have to empty their breasts with a pump. The pump does not have the same physiological effect as breastfeeding on the milk injection response.
Due to some problems arising from the breast or the baby, the baby may have problems in grasping and holding the breast. In such cases, a breastfeeding support system can be used.
The breastfeeding support system is based on the logic of stimulating the formation of prolactin by the baby's sucking of the milk, assuming that it comes from the breast, with the help of a plastic tube (usually a nasogastric tube) that is fixed to the breast on one end and the other end inside the bottle/container containing breast milk or formula.With this method, it is aimed to increase milk production and restart breastfeeding through active sucking of the newborn and stimulation of the breasts.
- Conditions
- Breastfeeding
- Being tested
- breastfeeding support system
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding support systemOther
Using the breastfeeding support system
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Breastfeeding support system will be applied to newborn babies in addition to breast milk. Receives: Other: breastfeeding support system |
| Control Group | No intervention | Newborn babies will receive breast milk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Diagnostic Measurement Tool
LATCH Breastfeeding Diagnostic Measurement The tool was developed by Jensen and Wallace in 1993 in Oregon. LATCH is a diagnostic tool created by analogy with the APGAR scoring system in terms of scoring method. Each item is evaluated between 0-2 points. The lowest 0 points and the highest 10 points are obtained from the scale. The Cronbach alpha coefficient of the LATCH Breastfeeding Diagnostic Measurement Tool was reported as 0.94 by Demirhan, 0.96 by Koyun, and 0.95 by Yenal and Okumuş.
Measured: After each breastfeeding an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Feb 2023
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma GUL CAN, Agri Ibrahim Cecen University
- Investigators
- Fatma GUL CAN, PhD, Principal investigator, Agri Ibrahim Cecen UniversityEda GÜLBETEKİN, PhD, Principal investigator, Igdir UniversitySelahattin KARAGÖZ KARAGÖZ, PhD, Principal investigator, Iğdır State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028581
- Sponsor's protocol ID
- AICU-GULCAN002
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Support System in Newborns on Developmental Findings and Discharge Time
- ClinicalTrials.gov ID
- NCT06028581
- Acronym / sponsor ID
- AICU-GULCAN002
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 8 Sep 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.
It is aimed to determine the effect of breastfeeding support system applied in newborns on developmental findings and discharge time.The research was planned as an experimental study with experimental and control groups. The population of the study consisted of babies who received care and treatment in Iğdır State Hospital Neonatal Intensive Care Clinic between February and June 2023. The sample of the study was calculated using the G*Power computer program. In the calculation made, it was found that a total of 70 children, 35 of each for the control and experimental groups, should be included. In this study, the experimental group consisted of 36 children and the control group consisted of 35 children. Children selected by simple random sampling method were divided into groups by randomization and which group would be the experimental group and which group would be the control group were determined by randomization. Masking was done during data collection and data analysis. The data is in the analysis stage.
Detailed description
Breast milk is a natural food with high bioavailability, easy to digest, which reduces the morbidity and mortality of the newborn, contains all the fluid, energy and nutrients necessary for physical, spiritual and mental development.Breastfeeding has a biological and emotional impact on mother and baby, has many immunological, psychological, social and economic benefits for both mother and baby, and is the best method for maternal health and healthy growth and development of infants.The bond between mother and baby after birth In the sensitive period in which successful breastfeeding will be established by establishing a new hospital, some babies need to be hospitalized in the neonatal intensive care unit (NICU) for various reasons. During hospitalization, mothers cannot be with their babies during all feedings and often have to empty their breasts with a pump. The pump does not have the same physiological effect as breastfeeding on the milk injection response.
Due to some problems arising from the breast or the baby, the baby may have problems in grasping and holding the breast. In such cases, a breastfeeding support system can be used.
The breastfeeding support system is based on the logic of stimulating the formation of prolactin by the baby's sucking of the milk, assuming that it comes from the breast, with the help of a plastic tube (usually a nasogastric tube) that is fixed to the breast on one end and the other end inside the bottle/container containing breast milk or formula.With this method, it is aimed to increase milk production and restart breastfeeding through active sucking of the newborn and stimulation of the breasts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: breastfeeding support systemBreastfeeding support system will be applied to newborn babies in addition to breast milk. |
| Control Group | No intervention | –Newborn babies will receive breast milk. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| breastfeeding support systemUsing the breastfeeding support system | Other | Experimental Group |
Primary outcome
LATCH Breastfeeding Diagnostic Measurement Tool
Time frame: After each breastfeeding an average of 4 days
LATCH Breastfeeding Diagnostic Measurement The tool was developed by Jensen and Wallace in 1993 in Oregon. LATCH is a diagnostic tool created by analogy with the APGAR scoring system in terms of scoring method. Each item is evaluated between 0-2 points. The lowest 0 points and the highest 10 points are obtained from the scale. The Cronbach alpha coefficient of the LATCH Breastfeeding Diagnostic Measurement Tool was reported as 0.94 by Demirhan, 0.96 by Koyun, and 0.95 by Yenal and Okumuş.
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 8 Sep 2023.
- 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.
Fatma GUL CAN, PhD principal investigator
Agri Ibrahim Cecen University
Eda GÜLBETEKİN, PhD principal investigator
Igdir University
Selahattin KARAGÖZ KARAGÖZ, PhD principal investigator
Iğdır State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding support system in people with Breastfeeding, run by Agri Ibrahim Cecen 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?
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 8 Sep 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?
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 Diagnostic Measurement Tool (time frame: After each breastfeeding an average of 4 days). 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 8 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.