Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

Sponsor

Boston College (Other)

Overall Status

Recruiting

CT.gov ID

NCT04942106

Collaborator

Beth Israel Deaconess Medical Center (Other), University of North Carolina, Chapel Hill (Other)

Enrollment

Location

Arms

14.7

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Feeding, Bottle Infant, Premature, Diseases Behavior, Infant	Other: Arm 1 - Side-lying position followed by Supine position Other: Arm 2 - Supine position followed by Side-lying position	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.
Other: 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.	Other: 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.

Arm

Intervention/Treatment

Other: 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.

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.

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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 - 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 - 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 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 - 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 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

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 - Maturity level [At enrollment]
Maturity level will be assessed by gestational age at birth
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 - 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 - 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jinhee Park, PhD, RN, Boston College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boston College

ClinicalTrials.gov Identifier:

NCT04942106

Other Study ID Numbers:

R21NR019874

First Posted:

Jun 28, 2021

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infant, Premature, Diseases

Study Results

No Results Posted as of Apr 6, 2022