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The Impact of Positioning on Bottle-feeding in Preterm Infants. A Comparative Study PMMHHRI-2018/V/9-SZB

The Impact of Positioning on Bottle-feeding in Preterm Infants ≤34 Gestational Age. A Comparative Study of the Semi-elevated and Side-lying Position

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04773613
Enrollment
42
Registered
2021-02-26
Start date
2018-07-19
Completion date
2020-04-20
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bottle Feeding, Premature

Keywords

Premature Infant, Bottle Feeding, Side-lying Position, Semi-elevated Position, Oral Feeding

Brief summary

One of the challenges of modern neonatology is to identify the right and effective method that can improve oral feeding. Optimal feeding position may contribute to improving the quality and safety of bottle-feeding in premature infants.

Detailed description

PURPOSE: The aim of the study was to compare the advantages of semi-elevated (SEP) with side-lying positioning (SLP) during bottle-feeding of preterm infants. METHOD: The study included forty two neonates (n=42) born ≤34 weeks of gestational age. Four bottle-feeding sessions were tested in each of the newborns: two in the SEP and two in the SLP. The position for the first study was randomly assigned, then positioning changed after each feeding session. In one day, only two consecutive feeding sessions which were included to the study in order to minimize fatigability as a disrupting factor. The levels of saturation (SpO2) and heart rate (HR) were measured as the parameters indicative of the newborn's physiological stability. The factors determining the qualitative aspect of feeding included the total time of declines of SpO2 ≤85%, level of the newborn's alertness according to the Neonatal Behavioral Assessment Scale (NBAS), and the occurrence of choking episodes. The proportion of milk consumed (volume of milk eaten relative to the expected volume) and the duration of the feeding and feeding session were also recorded.

Interventions

OTHERExperimental SLP

SLP was given to the infant during bottle-feeding.

OTHERExperimental SEP

SEP was given to the infant during bottle-feeding.

Sponsors

Polish Mother Memorial Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
32 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

* circulatory and respiratory stability; * readiness for oral feeding according to each child's Speech-Language Pathologist assessment; * prematurely born infants who were in the process of being transferred from enteral nutrition (or enteral nutrition + parenteral nutrition) to full oral feeding and were fed orally at least 4- 6 times within twenty-four hours; * parents gave informed consent to participate their infant in the study.

Exclusion criteria

* disorders which could significantly affect the feeding course, such as cleft lip and/or palate, facial paralysis and/or congenital defects of the facial skeleton; * the presence of detected congenital abnormalities and metabolic diseases; low Apgar score (less than 5 points at the 5th and 10th minute of the measurement); * administered analgesics, anticonvulsants and sedatives; * \<72 hours from extubation prior the trial; * parents refusal to participate in the study or when bottle-feeding was not the parental preference.

Design outcomes

Primary

MeasureTime frameDescription
Physiological stabilityMeasured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)Oxygen saturation (SpO2) changes measured by using a pulse oximeter data
Qualitative aspect of bottle-feedingMeasured during feedingTotal time of declines of SpO2 ≤85%

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026