Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

Infant, Premature, Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942106
• Other study ID #: R21NR019874
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Boston College
• Contact: Jinhee Park, PhD, RN
• Phone: 617-552-6542
• Email: jinhee.park[@]bc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Infant
• Feeding, Bottle
• Infant, Premature, Diseases

Intervention

Other:
• Arm 1 - Side-lying position followed by Supine position
Infants will be observed for two bottle feedings in a single day when they are receiving at least 30% and no more than 50% of feedings orally. 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
Infants will be observed for two bottle feedings in a single day when they are receiving at least 30% and no more than 50% of feedings orally. 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston College	Beth Israel Deaconess Medical Center, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Infant characteristics associated with the intervention response - Infant's sex	Infant's sex (female vs. male)	At enrollment
Secondary	Infant characteristics associated with the intervention response - Maturity level	Maturity level will be assessed by gestational age at birth	At enrollment
Secondary	Infant characteristics associated with the intervention response - Maturity level	Maturity level will be assessed by postmenstrual age at the time of study	At the end of the feeding observation, up to 30 minutes post-feeding
Secondary	Infant characteristics associated with the intervention response - Overall severity of illness	Overall severity illness score will be calculated using the Neonatal Medical Index (range of 1 [least severe] to 5 [most severe])	At discharge, up to 150 days
Secondary	Infant characteristics associated with the intervention response - Severity of lung disease	Severity of lung disease will be assessed using diagnostic criteria of bronchopulmonary dysplasia (none, mild, moderate, or severe)	At discharge, up to 150 days