Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
- Conditions
- Prematurity
- Interventions
- Other: Oral feeding
- Registration Number
- NCT01787019
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Gestational age <= 29 weeks at birth
- Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age
- Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30 weeks Oral feeding initiation of oral feedings at 30 weeks 33 weeks Oral feeding initiation of oral feedings at 33 weeks
- Primary Outcome Measures
Name Time Method Postmenstrual age at full oral feeding until hospital discharge (typically 36 weeks postmenstrual age) defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days
- Secondary Outcome Measures
Name Time Method growth between enrollment and 36 weeks postmenstrual age until hospital discharge (typically 36 weeks postmenstrual age) postmenstrual age at discharge until hospital discharge (typically 36 weeks postmenstrual age)
Trial Locations
- Locations (1)
Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States