Clinical trial NCT04942106: 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
Overall status: COMPLETED
Phase: NA
Conditions: Feeding, Bottle
Infant, Premature, Diseases
Behavior, Infant
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: University of North Carolina, Chapel Hill
First posted: 2021-06-28
Enrollment: 60
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Infant physiologic responses to the feeding position - Heart rate (HR)
timeFrame: Up to 30 minutes post-feeding
measure: Infant physiologic responses to the feeding position - Respiratory rate (RR)
timeFrame: Up to 30 minutes post-feeding
measure: Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
timeFrame: Up to 30 minutes post-feeding
measure: Infant physiologic responses to the feeding position - Heart rate variability (HRV)
timeFrame: Up to 30 minutes post-feeding
measure: Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)
timeFrame: Up to 30 minutes post-feeding
measure: Infant behavioral responses to the feeding position - Suck-breathe coordination
timeFrame: 5-30 minutes post-baseline
measure: Infant behavioral responses to the feeding position - Infant feeding skill
timeFrame: 5-30 minutes post-baseline
Secondary outcomes:
measure: Infant characteristics associated with the intervention response - Infant's sex
timeFrame: At enrollment
measure: Infant characteristics associated with the intervention response - Maturity level
timeFrame: At enrollment
measure: Infant characteristics associated with the intervention response - Maturity level
timeFrame: At the end of the feeding observation, up to 30 minutes post-feeding
measure: Infant characteristics associated with the intervention response - Overall severity of illness
timeFrame: At discharge, up to 150 days
measure: Infant characteristics associated with the intervention response - Severity of lung disease
timeFrame: At discharge, up to 150 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston College
name: Jinhee Park, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: