Clinical Trials Directory

Trials / Completed

CompletedNCT04987983

A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.

A Comparison Study of the Bottle-feeding of Prematurely Born Infants (≤ 34 Weeks of Gestational Age) in Side-lying Position, Positioned on the Right and Left Side - a Pilot Study.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Polish Mother Memorial Hospital Research Institute · Academic / Other
Sex
All
Age
32 Weeks – 38 Weeks
Healthy volunteers
Accepted

Summary

Methods and techniques to improve the quality and safety of oral feeding in preterm infants are still a significant challenge in modern neonatology. One of the areas that can help improve feeding is choosing the optimal feeding position for premature babies.

Detailed description

PURPOSE: The aim of the study is to compare the advantages of side-lying positioning on the right (SLP-R) and left side (SLP-L) of infant's body, during bottle-feeding of preterm infants. METHOD: The study will include eight neonates (n=8) born ≤34 weeks of gestational age. Four bottle-feeding sessions will be tested in each of the newborns: two in the SLP-R and two in the SLP-L. The position for the first study will be randomly assign, then positioning will be change after each feeding session. In one day, only two consecutive feeding sessions will be tested which will be included to the study in order to minimize fatigability as a disrupting factor. The levels of saturation (SpO2) and heart rate (HR) will be measured as the parameters indicative of the newborn's physiological stability. The factors determining the qualitative aspect of feeding include 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 will be record. Maximum time of feeding session will be 40 minutes. Also the posseting during/after feeding and regurgitations will be record in each tested positions.

Conditions

Interventions

TypeNameDescription
OTHERExperimental SLP-RSLP-R will be given to the infant during bottle-feeding.
OTHERExperimental SLP-LSLP-L will be given to the infant during bottle-feeding.

Timeline

Start date
2021-06-28
Primary completion
2021-09-08
Completion
2021-09-23
First posted
2021-08-03
Last updated
2023-03-21

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04987983. Inclusion in this directory is not an endorsement.