NCT05968586

Brief Summary

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

July 21, 2023

Last Update Submit

January 28, 2025

Conditions

Neonatal Oxygen DesaturationPrematureVentilator Lung; NewbornApnea of Prematurity

Keywords

apnea of prematurityNAVA

Outcome Measures

Primary Outcomes (5)

  • Peak electrical activity of the diaphragm (Edi peaks)

    Height of Edi signal in uV

    From enrollment in study to end of study (a total of twelve hours)

  • Minimum electrical activity of the diaphragm (Edi mins)

    Lowest of Edi signal in uV

    From enrollment in study to end of study (a total of twelve hours)

  • Number of apenic events

    Number of times where infant ceases to breath for \>5 seconds

    From enrollment in study to end of study (a total of twelve hours)

  • Number of bradycardia events

    Number of times where infant's heart rate drops \<100bpm sustained for \>5s

    From enrollment in study to end of study (a total of twelve hours)

  • Number of desaturation events

    Number of times where infant's oxygen saturation drops \<85% sustained for \>5s

    From enrollment in study to end of study (a total of twelve hours)

Study Arms (2)

Prone positioning

EXPERIMENTAL
Other: Body positioning

Supine positioning

ACTIVE COMPARATOR
Other: Body positioning

Interventions

Body positioningOTHER

Body positioning of infants prone vs supine.

Prone positioningSupine positioning

Eligibility Criteria

Age1 Minute - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
  • Infant must be stable on NAVA for at least 24 hours prior to the study

You may not qualify if:

  • Infants with congenital heart disease (CHD)
  • Infants with persistent pulmonary hypertension (PPHN)
  • Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Asphyxia NeonatorumPremature BirthBronchopulmonary DysplasiaApnea

Interventions

Posture

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristin Glass, MD

    Penn State College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatal-Perinatal Medicine Fellow

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 1, 2023

Study Start

September 11, 2023

Primary Completion

December 28, 2024

Study Completion

December 31, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)