Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

NCT ID: NCT04942106

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2024-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Side-lying position followed by Supine position

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

Group Type: OTHER

Arm 1 - Side-lying position followed by Supine position

Intervention Type: 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.

Supine position followed by Side-lying position

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

Group Type: OTHER

Arm 2 - Supine position followed by Side-lying position

Intervention Type: 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.

Interventions

Arm 1 - Side-lying position followed by Supine position

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.

Intervention Type: OTHER

Arm 2 - Supine position followed by Side-lying position

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Boston College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinhee Park, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Boston College

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39231735 (View on PubMed)

Other Identifiers

R21NR019874

Identifier Type: NIH

Identifier Source: org_study_id

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