Back to resultsEffect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
Primary Purpose
Feeding Behavior
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Semielevated Side-lying Position-ESL
Semielevated Supine Position
Sponsored by
About this trial
This is an interventional prevention trial for Feeding Behavior focused on measuring Feeding, preterm infant, physiological characteristics, position, ESL, ESU
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Semielevated Side-Lying Position-ESL
Semielevated Supine Position-ESU
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Oxygen Saturation
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
Heart Rate/Minute During Feeding
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.
Full Information
NCT ID
NCT02962609
First Posted
November 1, 2016
Last Updated
September 25, 2019
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT02962609
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behavior
Keywords
Feeding, preterm infant, physiological characteristics, position, ESL, ESU
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semielevated Side-Lying Position-ESL
Arm Type
Experimental
Arm Description
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.
Arm Title
Semielevated Supine Position-ESU
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Semielevated Side-lying Position-ESL
Intervention Description
The infants in the experimental group (n = 38) were held in the ESL position. In this position, their 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 infantswere held in the 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 their head and neck were held at the same level by the researcher; whereas, their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
Intervention Type
Other
Intervention Name(s)
Semielevated Supine Position
Intervention Description
The ESU position was applied to the infants in the control group (n=42). In this position, their head and trunk 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 they was laid in the supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
Primary Outcome Measure Information:
Title
Percentage of Oxygen Saturation
Description
Oxygen saturation were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding.
Time Frame
During feeding (maximum 30 min)
Secondary Outcome Measure Information:
Title
Heart Rate/Minute During Feeding
Description
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.
Time Frame
During feeding (maximum 30 min)
Other Pre-specified Outcome Measures:
Title
Feeding Performances
Description
Feeding duration (minute)
Time Frame
during feeding (maximum 30 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
38 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu AYKANAT GİRGİN
Organizational Affiliation
Istanbul University Florence Nightingale Faculty of Nursing
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
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