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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04975282
Other study ID # Cup feeding, Bottle feeding
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2020
Est. completion date May 20, 2020

Study information

Verified date July 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. This study aimed to evaluate bottle feeding and cup feeding in preterm infants on the outcomes of full breastfeeding and discharge time.


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.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date May 20, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Weeks to 34 Weeks
Eligibility 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 Design


Intervention

Device:
Bottle feeding
Bottle was used as an alternative oral feeding method for preterm infants.
Cup feeding
Cup was used as an alternative oral feeding method for preterm infants.

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From transition to breastfeeding, up to 1 week.
Primary 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. From admission to discharge, up to 4 weeks
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