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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semielevated Side-lying Position-ESL | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During feeding (maximum 30 min) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During feeding (maximum 30 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding Performances | Feeding duration (minute) | during feeding (maximum 30 min) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burcu AYKANAT GİRGİN | Istanbul University Florence Nightingale Faculty of Nursing | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Semielevated Side-Lying Position-ESL | Feeding 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group |
| FG001 | Semielevated Supine Position-ESU | Feeding Position. 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Semielevated Side-Lying Position-ESL | Feeding 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | SpO2% | During feeding (maximum 30 min) |
|
30 minutes after feeding
During the feeding, the infants in both groups were followed up in terms of their physiological-behavioral stress and fatigue symptoms in accordance with the cue-based feeding approach and the feeding was interrupted for a short time in case of these symptoms. The feeding was continued in case of the cues showing that they were ready to be fed again as well as physiological stability.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semielevated Side-Lying Position-ESL | Feeding 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duygu Gözen (Associate Professor) | Istanbul University | +902124400000 | 27082 | dgozen@istanbul.edu.tr |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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|
| Semielevated Supine Position | Other | 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. |
|
| BG001 | Semielevated Supine Position-ESU | Feeding Position. 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | postmenstural age (weeks) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Semielevated Supine Position-ESU | Feeding Position. 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Beats per min | During feeding (maximum 30 min) |
|
|
|
| Other Pre-specified | Feeding Performances | Feeding duration (minute) | Posted | Mean | Standard Deviation | minutes | during feeding (maximum 30 min) |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Semielevated Supine Position-ESU | Feeding Position. 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. Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group | 0 | 42 | 0 | 42 | 0 | 42 |
When the research is published, it has to describe that "this research is funded by Istanbul University Scientific Research Project"
| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| 30 min after the feeding |
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