Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

NCT ID: NCT01787019

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-04-30

Brief Summary

The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.

Detailed Description

Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.

Conditions

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

30 weeks

initiation of oral feedings at 30 weeks

Group Type: EXPERIMENTAL

Oral feeding

Intervention Type: OTHER

33 weeks

initiation of oral feedings at 33 weeks

Group Type: ACTIVE_COMPARATOR

Oral feeding

Intervention Type: OTHER

Interventions

Oral feeding

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Gestational age <= 29 weeks at birth
• Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age

Exclusion Criteria

• Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding

• Maximum Eligible Age: 7 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Kennedy

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

Age of Oral Feeding

Identifier Type: -

Identifier Source: org_study_id