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

NCT ID: NCT04975282

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2020-05-20

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.

Conditions

Preterm; Feeding, Bottle; Feeding Behavior; Feeding, Breast

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bottle Feeding

The bottle feeding method was being used in the NICU (1 January -31 December 2018).

Bottle feeding

Intervention Type: DEVICE

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 feeding

Intervention Type: DEVICE

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

Interventions

Bottle feeding

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

Intervention Type: DEVICE

Cup feeding

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Zühal Çamur

Principal Investigator RN, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zühal Çamur, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Bengü Çetinkaya, RN, PhD

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Cup feeding, Bottle feeding

Identifier Type: -

Identifier Source: org_study_id