Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

Prematurity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787019
• Other study ID #: Age of Oral Feeding
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 4, 2013
• Last updated: May 12, 2016
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• Oral feeding

Locations

Country	Name	City	State
United States	Children's Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	average FiO2		at 33 weeks postmenstrual age	Yes
Other	use of positive pressure (yes/no)		33 weeks postmenstrual age	Yes
Primary	Postmenstrual age at full oral feeding	defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days	until hospital discharge (typically 36 weeks postmenstrual age)	No
Secondary	postmenstrual age at discharge		until hospital discharge (typically 36 weeks postmenstrual age)	No
Secondary	growth between enrollment and 36 weeks postmenstrual age		until hospital discharge (typically 36 weeks postmenstrual age)	No