Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

Study Overview
=================
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.

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

Conditions
-----------------
Feeding, Bottle, Infant, Premature, Diseases, Behavior, Infant

Intervention / Treatment
-----------------
* Other: Arm 1 - Side-lying position followed by Supine position
* Other: Arm 2 - Supine position followed by Side-lying position


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Side-lying position followed by Supine position<br>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<br>* 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.<br>|
| Other: Supine position followed by Side-lying position<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant characteristics associated with the intervention response - Infant's sex | Infant's sex (female vs. male) | At enrollment | 
| Infant characteristics associated with the intervention response - Maturity level | Maturity level will be assessed by gestational age at birth | At enrollment | 
| 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 | 
| 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 | 
| 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 |