Premature Birth
Conditions
Keywords
Prematurity, Oral Skills, Nasal CPAP oral feeds, HFNC oral feeds
Brief summary
The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.
Interventions
DIETARY_SUPPLEMENTOral Feed
Infant will be seen by occupational therapist (OT) twice a week and assessed for oral cues. If infant shows oral cues then the occupational therapist will proceed with feeding strategies. Oral feeding strategies include pacifier dips, open nipple trials with syringe controlled bolus size (1-4mls) and po trials up to 10mls.
DIETARY_SUPPLEMENTUsual care
Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
32 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* infants that require greater than 2 litres per minute (LPM) high flow nasal canula or CPAP with a max setting of 6cm H20 FiO2 30% or less for at least 72 hours or more * Tolerating enteral feeds of 120 ml/kg/day
Exclusion criteria
* Major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations) * Metabolic disorder * Major gastrointestinal surgeries * Patent ductus arteriosus (PDA) ligation surgery * Outborn deliveries greater than 7 days old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours | 2 months after enrollment | Measured in the electronic medical record |
Secondary
| Measure | Time frame |
|---|---|
| PMA at completion of first oral feed | 1 month after enrollment. |
| length of hospitalization | up to 6 months after admission |
| number of gastrostomy tube | up to 6 months after admission |
| oxygen at discharge | up to 6 months after admission |
| safety outcomes during the feed as measured by the number of desaturations | 2 months after enrollment |
| PMA at hospital discharge | up to 6 months after admission |
| safety outcomes during the feed as measured by the number of bradycardia episodes | 2 months after enrollment |
| safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed | 2 months after enrollment |
| safety outcomes as measured by the increase in flow after feed | 2 months after enrollment |
| safety outcomes as measured by the number of choking episodes | 2 months after enrollment |
| safety outcomes as measured by the number of episodes of aspiration pneumonia | 2 months after enrollment |
| safety outcomes during the feed as measured by the number of apnea episodes | 2 months after enrollment |
Countries
United States
Contacts
Primary ContactAshley N Morin, MD
Outcome results
None listed