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Completed

NCT Number: NCT02962609

Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics

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.

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Key information

Conditions

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

Age range

32 week–38 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Percentage of Oxygen Saturation

    Time frame: 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 outcomes

  1. Heart Rate/Minute During Feeding

    Time frame: 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 outcomes

  1. Feeding Performances

    Time frame: during feeding (maximum 30 min)

    Feeding duration (minute)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 11, 2016
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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