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Clinical Trials/NCT02962609
NCT02962609CompletedNot Applicable

Comparing the Effect of Feeding Preterm Infants in Two Different Positions on Some Physiological Characteristics: A Randomized-Controlled Trial

Istanbul University0 sites80 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Primary Endpoint
Percentage of Oxygen Saturation

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Care Provider)

Eligibility Criteria

Ages
32 Weeks to 38 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Semielevated Side-Lying Position-ESL

Experimental

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.

Intervention: Semielevated Side-lying Position-ESL (Other)

Semielevated Supine Position-ESU

Experimental

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.

Intervention: Semielevated Supine Position (Other)

Outcomes

Primary Outcomes

Percentage of Oxygen Saturation

Time Frame: 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 Outcomes

  • Heart Rate/Minute During Feeding(During feeding (maximum 30 min))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

DUYGU GOZEN

Associate Professor of Nursing Faculty

Istanbul University

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