Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

NCT04942106 | Completed

• 1 other identifier: R21NR019874
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Feeding, Bottle; Infant, Premature, Diseases; Behavior, Infant

Outcome Measures

Primary Outcomes (7)

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

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

  Up to 30 minutes post-feeding

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

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

  Up to 30 minutes post-feeding

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

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

  Up to 30 minutes post-feeding

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

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

  Up to 30 minutes post-feeding

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

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

  Up to 30 minutes post-feeding

• Infant behavioral responses to the feeding position - Suck-breathe coordination

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

  5-30 minutes post-baseline

• Infant behavioral responses to the feeding position - Infant feeding skill

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

  5-30 minutes post-baseline

Secondary Outcomes (5)

• Infant characteristics associated with the intervention response - Infant's sex

  At enrollment

• Infant characteristics associated with the intervention response - Maturity level

  At enrollment

• Infant characteristics associated with the intervention response - Maturity level

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

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

  At discharge, up to 150 days

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

  At discharge, up to 150 days

Study Arms (2)

Side-lying position followed by Supine position

OTHER

In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position.

Other: Arm 1 - Side-lying position followed by Supine position

Supine position followed by Side-lying position

OTHER

In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position.

Other: Arm 2 - Supine position followed by Side-lying position

Interventions

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.

Side-lying position followed by Supine position

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.

Supine position followed by Side-lying position

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston College: lead
• Beth Israel Deaconess Medical Center: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Park J, Thoyre S, Smallcomb J, Mcternan M, Kneeland T. Biobehavioral Efficacy of the Elevated Side-Lying Position for Feeding Preterm Infants: Study Protocol. J Adv Nurs. 2025 May;81(5):2819-2827. doi: 10.1111/jan.16444. Epub 2024 Sep 4.

  PMID: 39231735 DERIVED

MeSH Terms

Conditions

Bottle Feeding; Infant, Premature, Diseases; Infant Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Jinhee Park, PhD, RN

  Boston College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 28, 2021
• Study Start: March 10, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The investigators plan to share data starting 6 months after publication upon request.
• Access Criteria: Investigators wishing to use the data will submit a written request to the PI and provide a data use agreement with Boston College, stating that the data will be used for scientific purposes. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. There will be no cost for data sharing. Data will be provided to the investigator in an appropriate confidential electronic format.

Locations

US (1)