Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

Not Applicable

Completed

• Conditions: Feeding, Bottle; Behavior, Infant; Infant, Premature, Diseases
• Interventions: Other: Arm 1 - Side-lying position followed by Supine position; Other: Arm 2 - Supine position followed by Side-lying position

• Registration Number: NCT04942106
• Lead Sponsor: Boston College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-28
• Study Start: 2022-03-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Side-lying position followed by Supine position	Arm 1 - 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.
Supine position followed by Side-lying position	Arm 2 - 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.

Primary Outcome Measures

Name	Time	Method
Infant physiologic responses to the feeding position - Respiratory rate (RR)	Up to 30 minutes post-feeding	RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)	Up to 30 minutes post-feeding	SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Heart rate variability (HRV)	Up to 30 minutes post-feeding	HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Heart rate (HR)	Up to 30 minutes post-feeding	HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)	Up to 30 minutes post-feeding	SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Infant behavioral responses to the feeding position - Suck-breathe coordination	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.
Infant behavioral responses to the feeding position - Infant feeding skill	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 Outcome Measures

Name	Time	Method
Infant characteristics associated with the intervention response - Infant's sex	At enrollment	Infant's sex (female vs. male)
Infant characteristics associated with the intervention response - Overall severity of illness	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 \[most severe\])
Infant characteristics associated with the intervention response - Maturity level	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
Infant characteristics associated with the intervention response - Severity of lung disease	At discharge, up to 150 days	Severity of lung disease will be assessed using diagnostic criteria of bronchopulmonary dysplasia (none, mild, moderate, or severe)

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States