Clinical trial NCT02962609: Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
Official title: Comparing the Effect of Feeding Preterm Infants in Two Different Positions on Some Physiological Characteristics: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Keywords: Feeding
preterm infant
physiological characteristics
position
ESL
ESU
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 80
Sex: ALL
Minimum age (years): 32
Maximum age (years): 38
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants upon their physiological characteristics and feeding performances.

Detailed description: Semielevated supine position (ESU) is a position frequently used in neonatal intensive care units. In this position, infant is laid and fed on its back and the head is elevated to an angle of 45-60° in order to reduce the respiratory load of lungs. The ESL position, head of the infant is elevated to an angle of 45-60° and the infant is fed in the side-lying position. Since this position mimics the breast-feeding position, very preterm infants are supported to utilize the advantages of breast-feeding. A randomization was provided in the sample group consisting of totally 80 infants and while 38 infants were included in the ESL (experimental) group, 42 infants were included in the ESU (control) group.In the power analysis repeated at the end of the study, the power of the study was determined as 87% at a reliability of 95%.

Eligibility criteria: Inclusion Criteria:

* To be born between 26-31+6 gestational weeks according to mother's last menstruation date,
* To be between 32-39+6 postmenstrual weeks during the study,
* Have a body weight above 1500 g,
* Have a full enteral feeding,
* To be in a transition from orogastric catheter feeding to oral feeding for less than 24 hours,
* Have an oral feeding in this process for at least once,
* Tolerate at least 80% of amount of food given lastly during oral feeding,
* Voluntarily signing of the written informed consent form by parents

Exclusion Criteria:

* Infants suffering from craniofacial abnormalities like cleft palate,
* cleft lip and facial muscle paralysis; gastrointestinal, neurological and genetic disorders (necrotising enterocolitis, intracranial haemorrhage, periventricular leukomalacia, hydrocephalia, down syndrome, omphalocele, gastroschisis, short bowel syndrome etc.)
* moderate and severe bronchopulmonary dysplasia (BPD) (Jobe \& Bancalari, 2001)
* patent ductus arteriosus requiring surgical therapy were excluded from the study

Primary outcomes:
measure: Percentage of Oxygen Saturation
timeFrame: During feeding (maximum 30 min)
Secondary outcomes:
measure: Heart Rate/Minute During Feeding
timeFrame: During feeding (maximum 30 min)
Other outcomes:
measure: Feeding Performances
timeFrame: during feeding (maximum 30 min)
Locations:
Study officials:
affiliation: Istanbul University Florence Nightingale Faculty of Nursing
name: Burcu AYKANAT GİRGİN
role: PRINCIPAL_INVESTIGATOR
References: