Trial Outcomes & Findings for Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics (NCT NCT02962609)
NCT ID: NCT02962609
Last Updated: 2019-10-18
Results Overview
Oxygen saturation were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
During feeding (maximum 30 min)
Results posted on
2019-10-18
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
42
|
|
Overall Study
COMPLETED
|
38
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
Baseline characteristics by cohort
| Measure |
Semielevated Side-Lying Position-ESL
n=38 Participants
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
|
Semielevated Supine Position-ESU
n=42 Participants
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
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
34 postmenstural age (weeks)
STANDARD_DEVIATION 1 • n=99 Participants
|
34 postmenstural age (weeks)
STANDARD_DEVIATION 1 • n=107 Participants
|
34 postmenstural age (weeks)
STANDARD_DEVIATION 1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
38 participants
n=99 Participants
|
42 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Semielevated Supine Position-ESU
n=42 Participants
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
|
Semielevated Side-Lying Position-ESL
n=38 Participants
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
|
|---|---|---|
|
Percentage of Oxygen Saturation
30 min after the feeding
|
96.7 SpO2%
Standard Deviation 2.8
|
97.9 SpO2%
Standard Deviation 1.7
|
|
Percentage of Oxygen Saturation
2 min Before the feeding
|
98.09 SpO2%
Standard Deviation 1.7
|
98.08 SpO2%
Standard Deviation 1.6
|
|
Percentage of Oxygen Saturation
During feeding
|
93.4 SpO2%
Standard Deviation 5.6
|
96.7 SpO2%
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Semielevated Supine Position-ESU
n=42 Participants
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
|
Semielevated Side-Lying Position-ESL
n=38 Participants
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
|
|---|---|---|
|
Heart Rate/Minute During Feeding
2 min Before the feeding
|
150.3 Beats per min
Standard Deviation 18.6
|
151.1 Beats per min
Standard Deviation 14.7
|
|
Heart Rate/Minute During Feeding
During feeding
|
164.3 Beats per min
Standard Deviation 6.0
|
155.8 Beats per min
Standard Deviation 11.1
|
|
Heart Rate/Minute During Feeding
30 min after the feeding
|
155.1 Beats per min
Standard Deviation 13.6
|
150.5 Beats per min
Standard Deviation 10.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during feeding (maximum 30 min)Feeding duration (minute)
Outcome measures
| Measure |
Semielevated Supine Position-ESU
n=42 Participants
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
|
Semielevated Side-Lying Position-ESL
n=38 Participants
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
|
|---|---|---|
|
Feeding Performances
|
15 minutes
Standard Deviation 6
|
13 minutes
Standard Deviation 5
|
Adverse Events
Semielevated Side-Lying Position-ESL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Semielevated Supine Position-ESU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee When the research is published, it has to describe that "this research is funded by Istanbul University Scientific Research Project"
- Publication restrictions are in place
Restriction type: OTHER