Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
Primary Purpose
Feeding, Bottle, Infant, Premature, Diseases, Behavior, Infant
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm 1 - Side-lying position followed by Supine position
Arm 2 - Supine position followed by Side-lying position
Sponsored by
About this trial
This is an interventional supportive care trial for Feeding, Bottle
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
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Side-lying position followed by Supine position
Supine position followed by Side-lying position
Arm Description
In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position.
In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position.
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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.
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.
Secondary Outcome Measures
Infant characteristics associated with the intervention response - Infant's sex
Infant's sex (female vs. male)
Infant characteristics associated with the intervention response - Maturity level
Maturity level will be assessed by gestational age at birth
Infant characteristics associated with the intervention response - Maturity level
Maturity level will be assessed by postmenstrual age at the time of study
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])
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)
Full Information
NCT ID
NCT04942106
First Posted
May 30, 2021
Last Updated
September 25, 2023
Sponsor
Boston College
Collaborators
Beth Israel Deaconess Medical Center, University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04942106
Brief Title
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
Official Title
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position for Feeding Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston College
Collaborators
Beth Israel Deaconess Medical Center, University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding, Bottle, Infant, Premature, Diseases, Behavior, Infant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Side-lying position followed by Supine position
Arm Type
Other
Arm Description
In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position.
Arm Title
Supine position followed by Side-lying position
Arm Type
Other
Arm Description
In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position.
Intervention Type
Other
Intervention Name(s)
Arm 1 - Side-lying position followed by Supine position
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Arm 2 - Supine position followed by Side-lying position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infant physiologic responses to the feeding position - Heart rate (HR)
Description
HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time Frame
Up to 30 minutes post-feeding
Title
Infant physiologic responses to the feeding position - Respiratory rate (RR)
Description
RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time Frame
Up to 30 minutes post-feeding
Title
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
Description
SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time Frame
Up to 30 minutes post-feeding
Title
Infant physiologic responses to the feeding position - Heart rate variability (HRV)
Description
HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time Frame
Up to 30 minutes post-feeding
Title
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)
Description
SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time Frame
Up to 30 minutes post-feeding
Title
Infant behavioral responses to the feeding position - Suck-breathe coordination
Description
Infant behavioral responses will be assessed by the behavioral observation of suck-breathe coordination patterns using Suck-Breath Coordination coding scheme.
Time Frame
5-30 minutes post-baseline
Title
Infant behavioral responses to the feeding position - Infant feeding skill
Description
Infant behavioral responses will be assessed by the behavioral observation of infant feeding skill using the Early Feeding Skills (EFS) assessment tool.
Time Frame
5-30 minutes post-baseline
Secondary Outcome Measure Information:
Title
Infant characteristics associated with the intervention response - Infant's sex
Description
Infant's sex (female vs. male)
Time Frame
At enrollment
Title
Infant characteristics associated with the intervention response - Maturity level
Description
Maturity level will be assessed by gestational age at birth
Time Frame
At enrollment
Title
Infant characteristics associated with the intervention response - Maturity level
Description
Maturity level will be assessed by postmenstrual age at the time of study
Time Frame
At the end of the feeding observation, up to 30 minutes post-feeding
Title
Infant characteristics associated with the intervention response - Overall severity of illness
Description
Overall severity illness score will be calculated using the Neonatal Medical Index (range of 1 [least severe] to 5 [most severe])
Time Frame
At discharge, up to 150 days
Title
Infant characteristics associated with the intervention response - Severity of lung disease
Description
Severity of lung disease will be assessed using diagnostic criteria of bronchopulmonary dysplasia (none, mild, moderate, or severe)
Time Frame
At discharge, up to 150 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinhee Park, PhD, RN
Phone
617-552-6542
Email
jinhee.park@bc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Camilia R Martin, MD, MS
Phone
6176673276
Email
cmartin1@bidmc.havard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhee Park, PhD, RN
Organizational Affiliation
Boston College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilia Martin, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A database will be established to store project data. This data will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. Presentations, abstracts, and manuscripts related to the work will also be centrally stored. Once the project is finished and all analyses are complete, it is our intention to make the study dataset available upon request.
IPD Sharing Time Frame
The investigators plan to share data starting 6 months after publication upon request.
IPD Sharing Access Criteria
Investigators wishing to use the data will submit a written request to the PI and provide a data use agreement with Boston College, stating that the data will be used for scientific purposes. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. There will be no cost for data sharing. Data will be provided to the investigator in an appropriate confidential electronic format.
Learn more about this trial
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
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