Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

Boston College

Status: Completed

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

Treatments: Other: Arm 1 - Side-lying position followed by Supine position; Other: Arm 2 - Supine position followed by Side-lying position

Study type: Interventional

Funder types: Other

Identifiers

NCT04942106

R21NR019874

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Side-lying position followed by Supine position

Other group

Description:

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

Treatment:

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

Supine position followed by Side-lying position

Other group

Description:

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

Treatment:

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