Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics

Not Applicable

Completed

• Conditions: Feeding Behavior
• Interventions: Other: Semielevated Supine Position; Other: Semielevated Side-lying Position-ESL

• Registration Number: NCT02962609
• Lead Sponsor: Istanbul University

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%.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-10
• Study Completion: 2016-06
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Results First Submitted: 2017-10-26
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-10-18
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semielevated Supine Position-ESU	Semielevated Supine Position	Before feeding: In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.
Semielevated Side-Lying Position-ESL	Semielevated Side-lying Position-ESL	Preterm infants feed in the ESL position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.

Primary Outcome Measures

Name	Time	Method
Percentage of Oxygen Saturation	During feeding (maximum 30 min)	Oxygen saturation were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding.

Secondary Outcome Measures

Name	Time	Method
Heart Rate/Minute During Feeding	During feeding (maximum 30 min)	Heart rate were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding. Feeding duration, feeding efficiency, and percentage of food intake were evaluated via a video during the feeding and recorded after the feeding.