Clinical trial NCT01787019: Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prematurity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 66
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postmenstrual age at full oral feeding
timeFrame: until hospital discharge (typically 36 weeks postmenstrual age)
Secondary outcomes:
measure: postmenstrual age at discharge
timeFrame: until hospital discharge (typically 36 weeks postmenstrual age)
measure: growth between enrollment and 36 weeks postmenstrual age
timeFrame: until hospital discharge (typically 36 weeks postmenstrual age)
Other outcomes:
measure: average FiO2
timeFrame: at 33 weeks postmenstrual age
measure: use of positive pressure (yes/no)
timeFrame: 33 weeks postmenstrual age
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
References: