Apnea of Prematurity, Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn
Conditions
Keywords
apnea of prematurity, NAVA
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.
Interventions
OTHERBody positioning
Body positioning of infants prone vs supine.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 3 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak electrical activity of the diaphragm (Edi peaks) | From enrollment in study to end of study (a total of twelve hours) | Height of Edi signal in uV |
| Minimum electrical activity of the diaphragm (Edi mins) | From enrollment in study to end of study (a total of twelve hours) | Lowest of Edi signal in uV |
| Number of apenic events | From enrollment in study to end of study (a total of twelve hours) | Number of times where infant ceases to breath for \>5 seconds |
| Number of bradycardia events | From enrollment in study to end of study (a total of twelve hours) | Number of times where infant's heart rate drops \<100bpm sustained for \>5s |
| Number of desaturation events | From enrollment in study to end of study (a total of twelve hours) | Number of times where infant's oxygen saturation drops \<85% sustained for \>5s |
Countries
United States
Outcome results
None listed