PretermNCT04975282
Comparison of Bottle and Cup Feeding on Transition to Full Breastfeeding and Discharge Time
An observational study of Preterm and Feeding, Bottle, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Breastfeeding is the ideal feeding method and that in the absence of breastfeeding the bottle and cup feeding are common alternatives. There is a lack of evidence regarding superiority of either of these methods. Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Feeding, Bottle, Feeding Behavior
- What is being tested?
- Bottle feeding and Cup feeding
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 20 May 2020
- Phase
- Observational
- 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 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants between 30-34 weeks and healthy
Who may be able to join
- Preterm infants (30-34 weeks);
- Considered medically stable
- With no facial deformity,
- Absent of neurological or congenital anomalies,
- Did not require sedation or vasoactive drugs
- Mother is providing breast milk \& plans to breastfeed.
Who cannot join
- Presence of gastrointestinal conditions that complicate feeding such as NEC,
- Absence of mother,
- Absence of breast milk, and
- Preterm infants fed only formula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Oral Feeding Methods in Preterm Infants on Transition to Full Breastfeeding and Discharge Time: A Retrospective Study
Breastfeeding is the ideal feeding method and that in the absence of breastfeeding the bottle and cup feeding are common alternatives. There is a lack of evidence regarding superiority of either of these methods. This study aimed to evaluate bottle feeding and cup feeding in preterm infants on the outcomes of full breastfeeding and discharge time.
Read the detailed description
An estimated 20 million infants are born preterm each year (>37 weeks) and this number is increasing. The preterm newborn population is potentially unable to be fed orally for a long time in the postnatal period.However, it is not a disease that preterm infants cannot be fed orally as soon as they are born. Since the physiological functions are not yet fully mature, their adaptation to the external uterine environment is more complicated.This situation also means a long hospital stay. Therefore, the American Academy of Pediatrics (AAP) has determined oral feeding of the preterm baby as the main criterion for discharge.
In preterm infants, sucking and swallowing coordination occurs in the 32 to 34 gestation weeks.Oral feeding skills are developed by applying various sensorimotor interventions and cue-based feeding protocols to increase oral feeding performance.Tube feeding (orogastric and nasogastric) is widely preferred as their oral-motor skills are still immature.As postnatal age increases, alternative oral feeding methods are often used along with tube feeding.Bottle feeding, cup feeding spoon feeding and syringe feeding are the most popular methods in clinical practice. While determining the most available method of oral feeding in preterm infants, the selection criteria include their capacity to facilitate the transition to full breastfeeding to help sustain breastfeeding to shorten the duration of hospitalization and to ensure sufficient nutrition.
Direct full breastfeeding is the important and most recommended feeding method in new-borns. However, since full breastfeeding is not immediately possible in preterm infants, they definitely need an alternative feeding method.
- Conditions
- Preterm, Feeding, Bottle, Feeding Behavior, Feeding, Breast
- Being tested
- Bottle feeding, Cup feeding
- Keywords
- Preterm infants, Bottle feeding, Cup feeding, Feeding methods, Breastfeeding
- Medical subject headings
- Premature Birth, Bottle Feeding, Feeding Behavior, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle feedingDevice
Bottle was used as an alternative oral feeding method for preterm infants.
Cup feedingDevice
Cup was used as an alternative oral feeding method for preterm infants.
| Study group | Role | What they receive |
|---|---|---|
| Bottle Feeding | The bottle feeding method was being used in the NICU (1 January -31 December 2018). Receives: Device: Bottle feeding | |
| Cup Feeding | The cup feeding method was being used in the NICU (1 January -31 December 2019). Receives: Device: Cup feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition to Full Breastfeeding
Preterm infants fed with bottle (n=78) and cup (n=80) were compared in terms of transition to full breastfeeding. The transition period from oral feeding to full breastfeeding is different for every preterm infants. There is no specific time frame in the study. For this outcome, infants were evaluated for time from oral feeding to full breastfeeding.
Measured: From transition to breastfeeding, up to 1 week.
Discharge Time
Preterm infants fed with bottle (n=78) and cup (n=80) were compared in terms of discharge times. There is no specific time frame in the study. For this outcome, infants were evaluated for lenght of stay hospital.
Measured: From admission to discharge, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start20 Feb 2020
- Primary completion30 Apr 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zühal Çamur, Pamukkale University
- Investigators
- Zühal Çamur, RN, PhD, Principal investigator, Pamukkale UniversityBengü Çetinkaya, RN, PhD, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975282
- Sponsor's protocol ID
- Cup feeding, Bottle feeding
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 23 Jul 2021
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Feeding Methods in Preterm Infants on Transition to Full Breastfeeding and Discharge Time: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04975282
- Acronym / sponsor ID
- Cup feeding, Bottle feeding
- Conditions
- Preterm, Feeding, Bottle, Feeding Behavior, Feeding, Breast
- Keywords
- Preterm infants, Bottle feeding, Cup feeding, Feeding methods, Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 23 Jul 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.
Breastfeeding is the ideal feeding method and that in the absence of breastfeeding the bottle and cup feeding are common alternatives. There is a lack of evidence regarding superiority of either of these methods. This study aimed to evaluate bottle feeding and cup feeding in preterm infants on the outcomes of full breastfeeding and discharge time.
Detailed description
An estimated 20 million infants are born preterm each year (>37 weeks) and this number is increasing. The preterm newborn population is potentially unable to be fed orally for a long time in the postnatal period.However, it is not a disease that preterm infants cannot be fed orally as soon as they are born. Since the physiological functions are not yet fully mature, their adaptation to the external uterine environment is more complicated.This situation also means a long hospital stay. Therefore, the American Academy of Pediatrics (AAP) has determined oral feeding of the preterm baby as the main criterion for discharge.
In preterm infants, sucking and swallowing coordination occurs in the 32 to 34 gestation weeks.Oral feeding skills are developed by applying various sensorimotor interventions and cue-based feeding protocols to increase oral feeding performance.Tube feeding (orogastric and nasogastric) is widely preferred as their oral-motor skills are still immature.As postnatal age increases, alternative oral feeding methods are often used along with tube feeding.Bottle feeding, cup feeding spoon feeding and syringe feeding are the most popular methods in clinical practice. While determining the most available method of oral feeding in preterm infants, the selection criteria include their capacity to facilitate the transition to full breastfeeding to help sustain breastfeeding to shorten the duration of hospitalization and to ensure sufficient nutrition.
Direct full breastfeeding is the important and most recommended feeding method in new-borns. However, since full breastfeeding is not immediately possible in preterm infants, they definitely need an alternative feeding method.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bottle Feeding | – | Device: Bottle feedingThe bottle feeding method was being used in the NICU (1 January -31 December 2018). |
| Cup Feeding | – | Device: Cup feedingThe cup feeding method was being used in the NICU (1 January -31 December 2019). |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants between 30-34 weeks and healthy
Key inclusion criteria (6 listed)
- Preterm infants (30-34 weeks);
- Considered medically stable
- With no facial deformity,
- Absent of neurological or congenital anomalies,
- Did not require sedation or vasoactive drugs
Key exclusion criteria (4 listed)
- Presence of gastrointestinal conditions that complicate feeding such as NEC,
- Absence of mother,
- Absence of breast milk, and
- Preterm infants fed only formula
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 |
|---|---|---|
| Bottle feedingBottle was used as an alternative oral feeding method for preterm infants. | Device | Bottle Feeding |
| Cup feedingCup was used as an alternative oral feeding method for preterm infants. | Device | Cup Feeding |
Primary outcome
Transition to Full Breastfeeding
Time frame: From transition to breastfeeding, up to 1 week.
Preterm infants fed with bottle (n=78) and cup (n=80) were compared in terms of transition to full breastfeeding. The transition period from oral feeding to full breastfeeding is different for every preterm infants. There is no specific time frame in the study. For this outcome, infants were evaluated for time from oral feeding to full breastfeeding.
Discharge Time
Time frame: From admission to discharge, up to 4 weeks
Preterm infants fed with bottle (n=78) and cup (n=80) were compared in terms of discharge times. There is no specific time frame in the study. For this outcome, infants were evaluated for lenght of stay hospital.
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 23 Jul 2021.
- 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.
Zühal Çamur, RN, PhD principal investigator
Pamukkale University
Bengü Çetinkaya, RN, PhD study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm and Feeding, Bottle, run by Pamukkale 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 6 inclusion and 4 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 23 Jul 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?
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?
Transition to Full Breastfeeding (time frame: From transition to breastfeeding, up to 1 week.). 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?
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 23 Jul 2021.