Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04531566

Conditions

Premature Birth

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Oral Feed

Usual care

Study Details

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.

Conditions

Premature Birth

Study ID

NCT04531566

Start date

Oct 20, 2020

Status verified date

May, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Feed Intervention Group

active comparator: Usual care

Interventions

Oral 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.

Usual 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.

Primary outcome measure

  • Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours [ Time Frame: 2 months after enrollment ]

Central Contacts and Locations

Central contacts

Ashley N Morin, MD

(713) 500-5800Ashley.N.Morin@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Ashley N Morin, MD

713-500-5800Ashley.N.Morin@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 23, 2022

Last verified

May, 2022

Keywords

  • Prematurity
  • Oral Skills
  • Nasal CPAP oral feeds
  • HFNC oral feeds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-05-23.