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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 weeks | Experimental | initiation of oral feedings at 30 weeks |
|
| 33 weeks | Active Comparator | initiation of oral feedings at 33 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral feeding | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| postmenstrual age at discharge | until hospital discharge (typically 36 weeks postmenstrual age) | |
| growth between enrollment and 36 weeks postmenstrual age | until hospital discharge (typically 36 weeks postmenstrual age) |
| Measure | Description | Time Frame |
|---|---|---|
| average FiO2 | at 33 weeks postmenstrual age | |
| use of positive pressure (yes/no) | 33 weeks postmenstrual age |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |