- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04975282
Comparison of Bottle and Cup Feeding on Transition to Full Breastfeeding and Discharge Time
The Effects of Oral Feeding Methods in Preterm Infants on Transition to Full Breastfeeding and Discharge Time: A Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey, 20160
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of gastrointestinal conditions that complicate feeding such as NEC,
- Absence of mother,
- Absence of breast milk, and
- Preterm infants fed only formula
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bottle Feeding
The bottle feeding method was being used in the NICU (1 January -31 December 2018).
|
Bottle was used as an alternative oral feeding method for preterm infants.
|
|
Cup Feeding
The cup feeding method was being used in the NICU (1 January -31 December 2019).
|
Cup was used as an alternative oral feeding method for preterm infants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From transition to breastfeeding, up to 1 week.
|
|
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.
|
From admission to discharge, up to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zühal Çamur, RN, PhD, Pamukkale University
- Study Director: Bengü Çetinkaya, RN, PhD, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cup feeding, Bottle feeding
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Feeding Behavior
-
Société des Produits Nestlé (SPN)Completed
-
University Hospitals Cleveland Medical CenterCompleted
-
The Hong Kong Polytechnic UniversityCompletedParents | Breast Feeding, ExclusiveHong Kong
-
Centre Hospitalier Régional d'OrléansRecruiting
-
Mayo ClinicRecruitingBreast FeedingUnited States
-
Loma Linda UniversityNot yet recruitingPregnancy Related | Breast Feeding, ExclusiveUnited States
-
Fundació Sant Joan de DéuNot yet recruiting
-
Sakarya UniversityNot yet recruiting
-
The University of Hong KongActive, not recruiting
Clinical Trials on Bottle feeding
-
Instituto Fernandes FigueiraTerminatedInfant, Very Low Birth WeightBrazil
-
Istanbul University - Cerrahpasa (IUC)CompletedNutritional Status | Heart Rate | Oxygen SaturationTurkey
-
Tel-Aviv Sourasky Medical CenterCompleted
-
California Polytechnic State University-San Luis...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
California Polytechnic State University-San Luis...CompletedBreastfeeding | Bottle Feeding | Mother-Infant InteractionUnited States
-
University of MalayaCompletedDental Caries in Children | Bottle FeedingMalaysia
-
Leann BirchCompletedBody Weight | Maternal Behavior | Infant Behavior
-
Duke UniversityNational Institutes of Health (NIH)Active, not recruitingPediatric Obesity | Infant Obesity | Weight Gain TrajectoryUnited States
-
California Polytechnic State University-San Luis...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Completed