Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics

NCT02962609 | Completed Results DMC

• 1 other identifier: 48252- BAP IU
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Feeding Behavior

Keywords

Feeding; preterm infant; physiological characteristics; position; ESL; ESU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart Rate/Minute During Feeding

  During feeding (maximum 30 min)

Other Outcomes (1)

• Feeding Performances

  during feeding (maximum 30 min)

Study Arms (2)

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.

Other: Semielevated Side-lying Position-ESL

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.

Other: Semielevated Supine Position

Interventions

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.

Semielevated Side-Lying Position-ESL

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.

Semielevated Supine Position-ESU

Eligibility Criteria

• Age: 32 Weeks - 38 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Feeding Behavior; Premature Birth

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Duygu Gözen (Associate Professor)
• Organization: Istanbul University

dgozen@istanbul.edu.tr

+902124400000

Study Officials

• Burcu AYKANAT GİRGİN

  Istanbul University Florence Nightingale Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing Faculty

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 11, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 18, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share