Premature Birth Clinical Trial
Official title:
Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 32 Weeks and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours | Measured in the electronic medical record | 2 months after enrollment | |
Secondary | PMA at hospital discharge | up to 6 months after admission | ||
Secondary | PMA at completion of first oral feed | 1 month after enrollment. | ||
Secondary | length of hospitalization | up to 6 months after admission | ||
Secondary | number of gastrostomy tube | up to 6 months after admission | ||
Secondary | oxygen at discharge | up to 6 months after admission | ||
Secondary | safety outcomes during the feed as measured by the number of desaturations | 2 months after enrollment | ||
Secondary | safety outcomes during the feed as measured by the number of apnea episodes | 2 months after enrollment | ||
Secondary | safety outcomes during the feed as measured by the number of bradycardia episodes | 2 months after enrollment | ||
Secondary | safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed | 2 months after enrollment | ||
Secondary | safety outcomes as measured by the increase in flow after feed | 2 months after enrollment | ||
Secondary | safety outcomes as measured by the number of choking episodes | 2 months after enrollment | ||
Secondary | safety outcomes as measured by the number of episodes of aspiration pneumonia | 2 months after enrollment |
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