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Completed

NCT Number: NCT04942106

Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.

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Key information

Conditions

Feeding, Bottle Behavior Behavior, Infant Bottle Feeding Child Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Behavior Infant Behavior Infant, Newborn, Diseases Infant, Premature, Diseases

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm infants who are born at ≤ 35 weeks of GA

Exclusion criteria

  • Congenital anomaly that may interfere with feeding (e.g., cleft palate or tracheoesophageal fistula)
  • Grade IV intraventricular hemorrhage
  • Ventilator-dependence beyond 60 days of life
  • Inability to orally feed prior to discharge

Treatment and study plan

Arm 1 - Side-lying position followed by Supine position

Other

Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.

Arm 2 - Supine position followed by Side-lying position

Other

Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.

Primary outcomes

  1. Infant physiologic responses to the feeding position - Heart rate (HR)

    Time frame: Up to 30 minutes post-feeding

    HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).

  2. Infant physiologic responses to the feeding position - Respiratory rate (RR)

    Time frame: Up to 30 minutes post-feeding

    RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).

  3. Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)

    Time frame: Up to 30 minutes post-feeding

    SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).

  4. Infant physiologic responses to the feeding position - Heart rate variability (HRV)

    Time frame: Up to 30 minutes post-feeding

    HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).

  5. Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)

    Time frame: Up to 30 minutes post-feeding

    SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).

  6. Infant behavioral responses to the feeding position - Suck-breathe coordination

    Time frame: 5-30 minutes post-baseline

    Infant behavioral responses will be assessed by the behavioral observation of suck-breathe coordination patterns using Suck-Breath Coordination coding scheme.

  7. Infant behavioral responses to the feeding position - Infant feeding skill

    Time frame: 5-30 minutes post-baseline

    Infant behavioral responses will be assessed by the behavioral observation of infant feeding skill using the Early Feeding Skills (EFS) assessment tool.

Secondary outcomes

  1. Infant characteristics associated with the intervention response - Infant's sex

    Time frame: At enrollment

    Infant's sex (female vs. male)

  2. Infant characteristics associated with the intervention response - Maturity level

    Time frame: At enrollment

    Maturity level will be assessed by gestational age at birth

  3. Infant characteristics associated with the intervention response - Maturity level

    Time frame: At the end of the feeding observation, up to 30 minutes post-feeding

    Maturity level will be assessed by postmenstrual age at the time of study

  4. Infant characteristics associated with the intervention response - Overall severity of illness

    Time frame: At discharge, up to 150 days

    Overall severity illness score will be calculated using the Neonatal Medical Index (range of 1 [least severe] to 5 [most severe])

  5. Infant characteristics associated with the intervention response - Severity of lung disease

    Time frame: At discharge, up to 150 days

    Severity of lung disease will be assessed using diagnostic criteria of bronchopulmonary dysplasia (none, mild, moderate, or severe)

Sponsors and collaborators

Lead sponsor

Boston College

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position for Feeding Preterm Infants

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2021
Registry last updated
Jul 12, 2024

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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