CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 211 enrolled
Drug / intervention
Oralstimulationother
Likely dose
Not stated in record
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Search/NCT02952950
NCT02952950N/ACompleted

Is it Possible to Prolong the Duration of Exclusive Breastfeeding in Premature Infants? a Prospectivt Study

Hvidovre University Hospital·interventional·Posted Nov 2, 2016·Updated Sep 25, 2019

In Brief

A clinical study evaluating Oralstimulation for Breast Feeding and Premature Birth. Completed, enrolled 211 participants across 1 site.

Detailed Summary

In this project three studies examined two possible explanations and one possible preventive intervention to early cessation of exclusively breastfeeding in premature infants. Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a third higher than in the milk from the mother who delivers on time. The nutritional composition changes over time and the content of protein decrease. Therefore the premature infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing content of protein can made up by adding, while it is more difficult when the infant is exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is associated to a fewer number of days where the premature infant is exclusively breastfed. Study 2 The premature infant is characterized with immature muscle with a low tension and therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of milk from mother to child is an interaction between the mothers and her milk ejection reflex that establish a positive pressure on the milk and the child that have to establish a vacuum. The hypothesis is that the premature infants suction power is too weak to establish sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can be related to a fewer number of days where the infant is exclusively breastfed. Study 3 The premature infants low muscle tone and its immaturity also influence on the organization and the quality of movements, marked as neuro motor processes. These processes form the oral motor base supporting movement which involves the infant ability to establish vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to create intra oral vacuum and thus the power to transfer milk from the breast, thereby extending the number of days when the infant is exclusively breastfed. 200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1 the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant suction is assessed by vacuum measurement. In study 3 the families are randomized to an intervention or control group and parents off 100 infants are guided by occupational therapists in a program of oral stimulation of their child.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2, 2016
Enrollment StartSep 1, 2016
Primary CompletionSep 1, 2018
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.7 years ago

Interventions

Oralstimulationother

The intervention group granted in total 1 hour instructions in a program of oral stimulation by one of two occupational therapists with experience in oral stimulation of preterm infants. The first guidance for parents has duration of approximately half an hour and then follow-up once or twice, depending on the needs of the family. To maintain consistent intervention over time is the program of oral stimulation written in a script, where the family also must record the following variables: date and time of oral stimulation. In occupational therapy the guidance and in the script examines the signs that the infant exhibits when it is ready / not ready for stimulation. The family also sees a movie where these signs and the program of oral stimulation review auditory and visual.