Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics

Feeding Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962609
• Other study ID #: 48252- BAP IU
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 38 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior
• Premature Birth

Intervention

Other:
• Semielevated 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.
• Semielevated 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feeding Performances	Feeding duration (minute)	during feeding (maximum 30 min)
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.	During feeding (maximum 30 min)
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.	During feeding (maximum 30 min)