Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position
NCT04942106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-07-12
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.
Conditions
- Feeding, Bottle
- Infant, Premature, Diseases
- Behavior, Infant
Interventions
- OTHER
-
Arm 1 - Side-lying position followed by Supine position
Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. 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
-
Arm 2 - Supine position followed by Side-lying position
Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. 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.
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
University of North Carolina, Chapel Hill
collaborator OTHER -
Boston College
lead OTHER
Principal Investigators
-
Jinhee Park, PhD, RN · Boston College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Max Age
- 2 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-10
- Primary Completion
- 2024-05-31
- Completion
- 2024-05-31
Countries
- United States
Study Locations
More Related Trials
-
The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation
NCT05509621 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Positioning in Preterm Neonates
NCT04251260 ·Status: UNKNOWN ·Phase: NA
-
Effect of Three Different Post-Feeding Positions on Vital Signs and Comfort Levels in Preterm Infants
NCT06473350 ·Status: COMPLETED ·Phase: NA
-
Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
NCT05777512 ·Status: RECRUITING ·Phase: NA
-
Effects of Clustering Care on the Physiological Stability of Preterm Infants.
NCT03490721 ·Status: COMPLETED ·Phase: NA
-
The Effect of Body Position on Oropharyngeal Swallow Function in Infants
NCT05874102 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation
NCT03895242 ·Status: COMPLETED ·Phase: NA
-
Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants
NCT01649362 ·Status: COMPLETED ·Phase: NA
-
Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding
NCT00703950 ·Status: TERMINATED ·Phase: PHASE4
-
Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
NCT00491660 ·Status: COMPLETED ·Phase: NA
-
Determining Optimal Dosage of Prone Positioning in Early Infancy
NCT03134859 ·Status: UNKNOWN ·Phase: NA
-
Effects of Swaddling on Infants During Feeding
NCT02661360 ·Status: COMPLETED ·Phase: NA
-
Comparison of the Results of Premature Babies Started Complementary Feeding
NCT04499430 ·Status: UNKNOWN
-
Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
NCT05434364 ·Status: COMPLETED ·Phase: NA
-
Positive Feeding of the Preterm Infant
NCT06189352 ·Status: RECRUITING ·Phase: NA
-
Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes
NCT03479515 ·Status: COMPLETED
-
Feeding Progression in Preterm Infants
NCT02027688 ·Status: COMPLETED ·Phase: NA
-
Pulmonary Function During Prone and Supine Positioning in NICU Infants Requiring Assisted Ventilation
NCT00749762 ·Status: WITHDRAWN
-
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
NCT05968586 ·Status: COMPLETED ·Phase: NA
-
Facilitated Tucking Position During Endotracheal Suctioning
NCT06428916 ·Status: COMPLETED ·Phase: NA
-
The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
NCT03546543 ·Status: COMPLETED ·Phase: NA
-
Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding of Preterm Infants
NCT05683210 ·Status: COMPLETED ·Phase: NA
-
Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation
NCT02034903 ·Status: UNKNOWN ·Phase: NA
-
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
NCT04890158 ·Status: TERMINATED ·Phase: NA
-
The Developmental Effects of NICU Positioning
NCT01628510 ·Status: COMPLETED ·Phase: NA