Clinical trial NCT04975282: Comparison of Bottle and Cup Feeding on Transition to Full Breastfeeding and Discharge Time
Official title: The Effects of Oral Feeding Methods in Preterm Infants on Transition to Full Breastfeeding and Discharge Time: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm
Feeding, Bottle
Feeding Behavior
Feeding, Breast
Keywords: Preterm infants
Bottle feeding
Cup feeding
Feeding methods
Breastfeeding
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants between 30-34 weeks and healthy

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.

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

Primary outcomes:
measure: Transition to Full Breastfeeding
timeFrame: From transition to breastfeeding, up to 1 week.
measure: Discharge Time
timeFrame: From admission to discharge, up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Zühal Çamur, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Bengü Çetinkaya, RN, PhD
role: STUDY_DIRECTOR
References: