Preterm InfantsNCT06737796
The Effect of Different Feeding Methods on Infants
A study testing Finger Feeding and syringe feeding in people with Preterm Infants and Injector, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to investigate the effect of finger feeding and syringe feeding methods on infant weight, time to full oral feeding and breastfeeding success in preterm infants. H01: There is no difference between the weights of preterm babies fed by finger and by syringe. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Injector, Finger
- What is being tested?
- Finger Feeding and syringe feeding
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Jan 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 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having a gestational age between 32 weeks and 36+6 weeks,
- Weighing 1500 g or more,
- Having spontaneous breathing (can receive free oxygen, incubator oxygen),
- Those who have been fed only by gavage or parenterally and are ready to switch to oral feeding,
- Preterm babies whose parents were literate in Turkish and gave consent were included in the study.
Who cannot join
- Those who were fed orally before the research,
- Those who need noninvasive mechanical ventilation such as CPAP,
- Babies with metabolic diseases were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes Univercity
Aydin, efeler, 0900
About this study
Official title: The Effect of Different Feeding Methods on Infant's Weight, Full Oral Feeding Transition Time and Success of Breastfeeding in Preterm Infants
Objective: The aim of this study was to investigate the effect of finger feeding and syringe feeding methods on infant weight, time to full oral feeding and breastfeeding success in preterm infants.
H01: There is no difference between the weights of preterm babies fed by finger and by syringe.
H02: There is no difference in the transition time between finger-fed and syringe-fed preterm babies to full oral feeding.
H03: There is no difference between breastfeeding success between finger and syringe feeding methods.
Read the detailed description
The study was conducted as a parallel groups randomized experimental study. The study was conducted between December 1, 2021 and June 1, 2023 in the Neonatal Intensive Care Unit of Aydın Obstetrics and Gynecology Hospital. The sample included preterm infants with 320/7-366/7 gestation weeks who were receiving care and treatment in the neonatal intensive care unit. In the sample, n=38 infants were randomly assigned to study group 1 and n=36 infants to study group 2 and the study was completed with n=74 infants. The data were collected using the Preterm Infant Information Form, Preterm Infant Follow-up Form and LATCH Breastfeeding Diagnostic Measurement Tool. The babies selected for the study group were fed with the method of whichever study group they were added to (finger or syringe feeding) at three feeding meals each day. After switching to full oral feeding, breastfeeding success was measured with the breastfeeding diagnostic measurement tool (LATCH), which was used when the infants first held the breast and the time of transition to full oral feeding. The difference between groups was analyzed using Mann Whitney U analysis for non-normally distributed data and the difference between groups for normally distributed data was analyzed using independent two sample t test. Homogeneity of variances was assessed by Levene's test. Since the standard error indicates the spread of the means of the samples selected from the same population and the standard deviation indicates the distance of each individual in the group from the mean, the standard error values were given together with the means in the analyses comparing the group means.
- Conditions
- Preterm Infants, Injector, Finger, Sucking Success, Nursing Caries
- Being tested
- Finger Feeding, syringe feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger FeedingBehavioural
feeding method
syringe feedingBehavioural
feeding method
| Study group | Role | What they receive |
|---|---|---|
| experimental 1 | Experimental | Preterm babies in the finger feeding group, which constituted the study group, were finger fed by the neonatal intensive care nurse responsible for the baby's care, three times a day for no more than 20 minutes. If babies had breast milk during feedings, breast milk was given first. Formula milk was used when breast milk was not available. The amount of milk that the preterm baby should receive, determined by the neonatal specialist physician, was completed after the planned 20 minutes of feeding time and at other feeding meals during the day, according to the clinic's feeding protocol. In addition, preterm babies have three meals a day; Heart rate, respiration and saturation before and after feeding, and evaluation of feeding duration, amount of feeding and vomiting at the end of feeding were recorded in PBIF. The Preterm Baby Monitoring Form, which was planned to be used at this stage, was filled out by the neonatal intensive care nurse or the researcher. Receives: Behavioral: Finger Feeding |
| experimental 2 | Experimental | Preterm babies in the syringe feeding group, which constituted the other study group, were fed with a syringe three times a day for no more than 20 minutes by the neonatal intensive care nurse responsible for the baby's care. If babies had breast milk during feedings, breast milk was given first. Formula milk was used when breast milk was not available. The amount of milk that the preterm baby should receive, determined by the neonatal specialist physician, was completed after the planned 20 minutes of feeding time and at other feeding meals during the day, according to the clinic's feeding protocol. In addition, preterm babies have three meals a day; Heart rate, respiration and saturation before and after feeding, and evaluation of feeding duration, amount of feeding and vomiting at the end of feeding were recorded in PBIF. The Preterm Baby Monitoring Form, which was planned to be used at this stage, was filled out by the neonatal intensive care nurse or the researcher. Receives: Behavioral: syringe feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother and Preterm Baby Introductory Information Form (APBTBF):
Mother and Preterm Baby Introductory Information Form (APBTBF): The questionnaire prepared by the researcher in line with the literature includes introductory information about the preterm baby (delivery type, baby's birth date and time, hospitalization date and time, hospitalization diagnosis, gestational age, corrected gestational age, gender). , birth weight, birth length, birth head circumference, weight at the start of the study, birth order, whether the mother was breastfed or not, whether the mother was educated about expressing her milk, discharge weight, date and time of the baby's discharge from the hospital) and descriptive information about the mother (age, education). It consists of 22 questions asking about breastfeeding level, previous breastfeeding experience, breastfeeding duration if breastfeeding, and previous birth to a preterm baby).
Measured: avarege four days
Preterm Baby Follow-up Form (PBIF):
Preterm Baby Follow-up Form (PBIF): It is a follow-up form developed by the researcher in line with the literature in order to follow the preterm baby from the moment he starts feeding with an alternative feeding method. In this form, the preterm baby's birth, transition to oral feeding, transition to breastfeeding and discharge dates, as well as information on body weight, head circumference and height at these stages; Information on heart rate (HR), respiratory rate and oxygen saturation (SpO2) values before and after feeding, presence of vomiting after feeding, full oral feeding amounts and feeding durations are included.
Measured: avarege four days
Breastfeeding Diagnostic Measurement Tool (LATCH):
Breastfeeding Diagnostic Measurement Tool (LATCH): LATCH was developed by Deborah Jensen and Sheilla Wallace in 1993. The adaptation of the scale into Turkish and its validity and reliability studies were first carried out in a Master's Thesis study by Demirhan and Pek in 1997, but this study was not published. The second validity and reliability study was conducted by Yenal and Okumuş in 2003. In the application of the scale, the mother is observed by a midwife/nurse while breastfeeding, and the form is filled out by evaluating the mother and the baby in line with the criteria. The application time of the scale is 5-10 minutes. While the Cronbah alpha value of the original version of the vehicle was found to be 0.93, it was found to be 0.95 in the Turkish adaptation study. The measurement tool consists of five evaluation items/criteria.
Measured: avarege four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Dec 2021
- Primary completion1 Jun 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Yapar, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737796
- Sponsor's protocol ID
- Adnan Menderes Univercity
- Status last verified
- Dec 2024
- First submitted
- 17 Jan 2024
- Last updated
- 17 Dec 2024
- 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Feeding Methods on Infant's Weight, Full Oral Feeding Transition Time and Success of Breastfeeding in Preterm Infants
- ClinicalTrials.gov ID
- NCT06737796
- Acronym / sponsor ID
- Adnan Menderes Univercity
- Conditions
- Preterm Infants, Injector, Finger, Sucking Success, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Dec 2024 (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.
Objective: The aim of this study was to investigate the effect of finger feeding and syringe feeding methods on infant weight, time to full oral feeding and breastfeeding success in preterm infants.
H01: There is no difference between the weights of preterm babies fed by finger and by syringe.
H02: There is no difference in the transition time between finger-fed and syringe-fed preterm babies to full oral feeding.
H03: There is no difference between breastfeeding success between finger and syringe feeding methods.
Detailed description
The study was conducted as a parallel groups randomized experimental study. The study was conducted between December 1, 2021 and June 1, 2023 in the Neonatal Intensive Care Unit of Aydın Obstetrics and Gynecology Hospital. The sample included preterm infants with 320/7-366/7 gestation weeks who were receiving care and treatment in the neonatal intensive care unit. In the sample, n=38 infants were randomly assigned to study group 1 and n=36 infants to study group 2 and the study was completed with n=74 infants. The data were collected using the Preterm Infant Information Form, Preterm Infant Follow-up Form and LATCH Breastfeeding Diagnostic Measurement Tool. The babies selected for the study group were fed with the method of whichever study group they were added to (finger or syringe feeding) at three feeding meals each day. After switching to full oral feeding, breastfeeding success was measured with the breastfeeding diagnostic measurement tool (LATCH), which was used when the infants first held the breast and the time of transition to full oral feeding. The difference between groups was analyzed using Mann Whitney U analysis for non-normally distributed data and the difference between groups for normally distributed data was analyzed using independent two sample t test. Homogeneity of variances was assessed by Levene's test. Since the standard error indicates the spread of the means of the samples selected from the same population and the standard deviation indicates the distance of each individual in the group from the mean, the standard error values were given together with the means in the analyses comparing the group means.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental 1 | Experimental | Behavioral: Finger FeedingPreterm babies in the finger feeding group, which constituted the study group, were finger fed by the neonatal intensive care nurse responsible for the baby's care, three times a day for no more than 20 minutes. If babies had breast milk during feedings, breast milk was given first. Formula milk was used when breast milk was not available. The amount of milk that the preterm baby should receive, determined by the neonatal specialist physician, was completed after the planned 20 minutes of feeding time and at other feeding meals during the day, according to the clinic's feeding protocol. In addition, preterm babies have three meals a day; Heart rate, respiration and saturation before and after feeding, and evaluation of feeding duration, amount of feeding and vomiting at the end of feeding were recorded in PBIF. The Preterm Baby Monitoring Form, which was planned to be used at this stage, was filled out by the neonatal intensive care nurse or the researcher. |
| experimental 2 | Experimental | Behavioral: syringe feedingPreterm babies in the syringe feeding group, which constituted the other study group, were fed with a syringe three times a day for no more than 20 minutes by the neonatal intensive care nurse responsible for the baby's care. If babies had breast milk during feedings, breast milk was given first. Formula milk was used when breast milk was not available. The amount of milk that the preterm baby should receive, determined by the neonatal specialist physician, was completed after the planned 20 minutes of feeding time and at other feeding meals during the day, according to the clinic's feeding protocol. In addition, preterm babies have three meals a day; Heart rate, respiration and saturation before and after feeding, and evaluation of feeding duration, amount of feeding and vomiting at the end of feeding were recorded in PBIF. The Preterm Baby Monitoring Form, which was planned to be used at this stage, was filled out by the neonatal intensive care nurse or the researcher. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Having a gestational age between 32 weeks and 36+6 weeks,
- Weighing 1500 g or more,
- Having spontaneous breathing (can receive free oxygen, incubator oxygen),
- Those who have been fed only by gavage or parenterally and are ready to switch to oral feeding,
- Preterm babies whose parents were literate in Turkish and gave consent were included in the study.
Key exclusion criteria (3 listed)
- Those who were fed orally before the research,
- Those who need noninvasive mechanical ventilation such as CPAP,
- Babies with metabolic diseases were excluded from the study.
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 Feedingfeeding method | Behavioural | experimental 1 |
| syringe feedingfeeding method | Behavioural | experimental 2 |
Primary outcome
Mother and Preterm Baby Introductory Information Form (APBTBF):
Time frame: avarege four days
Mother and Preterm Baby Introductory Information Form (APBTBF): The questionnaire prepared by the researcher in line with the literature includes introductory information about the preterm baby (delivery type, baby's birth date and time, hospitalization date and time, hospitalization diagnosis, gestational age, corrected gestational age, gender). , birth weight, birth length, birth head circumference, weight at the start of the study, birth order, whether the mother was breastfed or not, whether the mother was educated about expressing her milk, discharge weight, date and time of the baby's discharge from the hospital) and descriptive information about the mother (age, education). It consists of 22 questions asking about breastfeeding level, previous breastfeeding experience, breastfeeding duration if breastfeeding, and previous birth to a preterm baby).
Preterm Baby Follow-up Form (PBIF):
Time frame: avarege four days
Preterm Baby Follow-up Form (PBIF): It is a follow-up form developed by the researcher in line with the literature in order to follow the preterm baby from the moment he starts feeding with an alternative feeding method. In this form, the preterm baby's birth, transition to oral feeding, transition to breastfeeding and discharge dates, as well as information on body weight, head circumference and height at these stages; Information on heart rate (HR), respiratory rate and oxygen saturation (SpO2) values before and after feeding, presence of vomiting after feeding, full oral feeding amounts and feeding durations are included.
Breastfeeding Diagnostic Measurement Tool (LATCH):
Time frame: avarege four days
Breastfeeding Diagnostic Measurement Tool (LATCH): LATCH was developed by Deborah Jensen and Sheilla Wallace in 1993. The adaptation of the scale into Turkish and its validity and reliability studies were first carried out in a Master's Thesis study by Demirhan and Pek in 1997, but this study was not published. The second validity and reliability study was conducted by Yenal and Okumuş in 2003. In the application of the scale, the mother is observed by a midwife/nurse while breastfeeding, and the form is filled out by evaluating the mother and the baby in line with the criteria. The application time of the scale is 5-10 minutes. While the Cronbah alpha value of the original version of the vehicle was found to be 0.93, it was found to be 0.95 in the Turkish adaptation study. The measurement tool consists of five evaluation items/criteria.
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 17 Dec 2024.
- 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.
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 and syringe feeding in people with Preterm Infants and Injector, run by Aydin Adnan Menderes 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 5 inclusion and 3 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 17 Dec 2024. 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?
Mother and Preterm Baby Introductory Information Form (APBTBF): (time frame: avarege four days). The study lists 3 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 17 Dec 2024.