Comparison of Bottle and Cup Feeding on Transition to Full Breastfeeding and Discharge Time

Completed

• Conditions: Feeding, Bottle; Preterm; Feeding, Breast; Feeding Behavior
• Interventions: Device: Cup feeding; Device: Bottle feeding

• Registration Number: NCT04975282
• Lead Sponsor: Pamukkale University

Brief 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.

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 Timeline

• Study Start: 2020-02-20
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-20
• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cup Feeding	Cup feeding	The cup feeding method was being used in the NICU (1 January -31 December 2019).
Bottle Feeding	Bottle feeding	The bottle feeding method was being used in the NICU (1 January -31 December 2018).

Primary Outcome Measures

Name	Time	Method
Transition to Full Breastfeeding	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	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.

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey