Finger FeedingNCT05928715
Effect of Finger Feeding
A study testing Finger feeding in people with Finger Feeding and Alternative Feeding Methods, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
With the planned study, it was aimed to determine the effect of finger feeding method on newborns in term babies. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Finger Feeding, Alternative Feeding Methods
- What is being tested?
- Finger feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Jun 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mother is 18 years or older Newborns 38 weeks and older Newborns who do not have any postnatal health problems and are followed up with the mother Babies taking formula supplements Babies who have difficulty breastfeeding There is no obstacle to breastfeeding or breastfeeding
Who cannot join
- Babies with sucking and swallowing dysfunction Babies with respiratory distress (respiratory rate over 60/min, babies with groaning, nasal wing breathing)
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University Faculty of Health Sciences
Amasya, 05100
About this study
Official title: Effect of Finger Feeding on Term Newborns: A Randomized Controlled Study
With the planned study, it was aimed to determine the effect of finger feeding method on newborns in term babies.
Read the detailed description
It was planned as a randomized controlled experimental study design.
Full randomization will be performed and infants who meet the inclusion criteria will be assigned to groups by flipping a coin.
On the toss of a coin, if heads came up then subject was allocated to the control group. If tails came up, then subject was allocated to the intervention group. This procedure was repeated for each mother.
Within the scope of the study, "Informed consent" will be obtained from the parents for infants who need formula supplementation or for infants fed with expressed breast milk by the decision of the Physician in the experimental and control groups.
Babies in the control group will continue to receive routine care and no intervention will be made on their feeding style. The researcher will be informed verbally and practically about the finger feeding method and the application steps to the mothers of the babies in the experimental group and to the family members who will support their feeding in baby care. In this direction, it will be ensured that expressed breast milk or formula support is given by finger feeding method.
- Conditions
- Finger Feeding, Alternative Feeding Methods
- Being tested
- Finger feeding
- Keywords
- Finger Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger feedingOther
The newborn will receive every expressed breast milk or formula support during the day with the finger feeding method.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | It is the group that will receive breast milk or formula by finger feeding. Receives: Other: Finger feeding |
| Control group | No intervention | No Intervention: control group attempt will not be implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding
Number of breastfeeding per day
Measured: 15 days after the start of the intervention
Expressed breast milk
amount of daily expressed breast milk intake
Measured: 15 days after the start of the intervention
Formula intake
amount of daily formula consumption
Measured: 15 days after the start of the intervention
finger feeding
number of finger feeding per day
Measured: 15 days after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 Apr 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger FeedingStudies 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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- Mustela Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928715
- Sponsor's protocol ID
- 106728
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be shared if requested and deemed appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Finger Feeding on Term Newborns: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05928715
- Acronym / sponsor ID
- 106728
- Conditions
- Finger Feeding, Alternative Feeding Methods
- Keywords
- Finger Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- Mustela Foundation
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 3 Jul 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.
With the planned study, it was aimed to determine the effect of finger feeding method on newborns in term babies.
Detailed description
It was planned as a randomized controlled experimental study design.
Full randomization will be performed and infants who meet the inclusion criteria will be assigned to groups by flipping a coin.
On the toss of a coin, if heads came up then subject was allocated to the control group. If tails came up, then subject was allocated to the intervention group. This procedure was repeated for each mother.
Within the scope of the study, "Informed consent" will be obtained from the parents for infants who need formula supplementation or for infants fed with expressed breast milk by the decision of the Physician in the experimental and control groups.
Babies in the control group will continue to receive routine care and no intervention will be made on their feeding style. The researcher will be informed verbally and practically about the finger feeding method and the application steps to the mothers of the babies in the experimental group and to the family members who will support their feeding in baby care. In this direction, it will be ensured that expressed breast milk or formula support is given by finger feeding method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Finger feedingIt is the group that will receive breast milk or formula by finger feeding. |
| Control group | No intervention | –No Intervention: control group attempt will not be implemented |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mother is 18 years or older Newborns 38 weeks and older Newborns who do not have any postnatal health problems and are followed up with the mother Babies taking formula supplements Babies who have difficulty breastfeeding There is no obstacle to breastfeeding or breastfeeding
Key exclusion criteria (2 listed)
- Babies with sucking and swallowing dysfunction Babies with respiratory distress (respiratory rate over 60/min, babies with groaning, nasal wing breathing)
- -
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 |
|---|---|---|
| Finger feedingThe newborn will receive every expressed breast milk or formula support during the day with the finger feeding method. | Other | Experimental group |
Primary outcome
Breastfeeding
Time frame: 15 days after the start of the intervention
Number of breastfeeding per day
Expressed breast milk
Time frame: 15 days after the start of the intervention
amount of daily expressed breast milk intake
Formula intake
Time frame: 15 days after the start of the intervention
amount of daily formula consumption
finger feeding
Time frame: 15 days after the start of the intervention
number of finger feeding per day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Undecided. It will be shared if requested and deemed appropriate.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger feeding in people with Finger Feeding and Alternative Feeding Methods, run by Amasya 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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
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?
Breastfeeding (time frame: 15 days after the start of the intervention). The study lists 4 primary outcomes in all. 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 3 Jul 2023.