Feeding Behavior
Conditions
Keywords
Feeding, preterm infant, physiological characteristics, position, ESL, ESU
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%.
Interventions
OTHERSemielevated Side-lying Position-ESL
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.
OTHERSemielevated Supine Position
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.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 38 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feeding Performances | during feeding (maximum 30 min) | Feeding duration (minute) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 42 |
| Total | 80 |
Baseline characteristics
| Characteristic | Semielevated Supine Position-ESU | Semielevated Side-Lying Position-ESL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 42 Participants | 38 Participants | 80 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 34 postmenstural age (weeks) STANDARD_DEVIATION 1 | 34 postmenstural age (weeks) STANDARD_DEVIATION 1 | 34 postmenstural age (weeks) STANDARD_DEVIATION 1 |
| Region of Enrollment Turkey | 42 participants | 38 participants | 80 participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 42 |
| other Total, other adverse events | 0 / 38 | 0 / 42 |
| serious Total, serious adverse events | 0 / 38 | 0 / 42 |
Outcome results
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.
Time frame: During feeding (maximum 30 min)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semielevated Side-Lying Position-ESL | Percentage of Oxygen Saturation | 2 min Before the feeding | 98.08 SpO2% | Standard Deviation 1.6 |
| Semielevated Side-Lying Position-ESL | Percentage of Oxygen Saturation | During feeding | 96.7 SpO2% | Standard Deviation 2.5 |
| Semielevated Side-Lying Position-ESL | Percentage of Oxygen Saturation | 30 min after the feeding | 97.9 SpO2% | Standard Deviation 1.7 |
| Semielevated Supine Position-ESU | Percentage of Oxygen Saturation | During feeding | 93.4 SpO2% | Standard Deviation 5.6 |
| Semielevated Supine Position-ESU | Percentage of Oxygen Saturation | 2 min Before the feeding | 98.09 SpO2% | Standard Deviation 1.7 |
| Semielevated Supine Position-ESU | Percentage of Oxygen Saturation | 30 min after the feeding | 96.7 SpO2% | Standard Deviation 2.8 |
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.
Time frame: During feeding (maximum 30 min)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semielevated Side-Lying Position-ESL | Heart Rate/Minute During Feeding | 30 min after the feeding | 150.5 Beats per min | Standard Deviation 10.7 |
| Semielevated Side-Lying Position-ESL | Heart Rate/Minute During Feeding | 2 min Before the feeding | 151.1 Beats per min | Standard Deviation 14.7 |
| Semielevated Side-Lying Position-ESL | Heart Rate/Minute During Feeding | During feeding | 155.8 Beats per min | Standard Deviation 11.1 |
| Semielevated Supine Position-ESU | Heart Rate/Minute During Feeding | 2 min Before the feeding | 150.3 Beats per min | Standard Deviation 18.6 |
| Semielevated Supine Position-ESU | Heart Rate/Minute During Feeding | During feeding | 164.3 Beats per min | Standard Deviation 6 |
| Semielevated Supine Position-ESU | Heart Rate/Minute During Feeding | 30 min after the feeding | 155.1 Beats per min | Standard Deviation 13.6 |
Other Pre-specified
Feeding Performances
Feeding duration (minute)
Time frame: during feeding (maximum 30 min)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semielevated Side-Lying Position-ESL | Feeding Performances | 13 minutes | Standard Deviation 5 |
| Semielevated Supine Position-ESU | Feeding Performances | 15 minutes | Standard Deviation 6 |