Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
研究概览
简要总结
The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.
详细描述
Inclusion criteria
- Healthy infants ≥ 35 weeks
- Neonates 36-96 hours old
- Exclusively breastfeeding
- TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- TSB < 6 hours ago
- Mothers English-speaking or Spanish-speaking
Outcome Measures
- Primary outcome: Total Serum Bilirubin
- Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 36 Hours 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants ≥ 35 weeks
- •Neonates 36-96 hours old
- •Exclusively breastfeeding
- •TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- •TSB < 6 hours ago
- •Mothers English-speaking or Spanish-speaking
排除标准
- •Infants who have already received formula
- •Infants who have received or are receiving Level II or Level III
- •Infants who have already lost ≥ 10% birth weight
- •Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
结局指标
主要结局
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
时间窗: Up to two weeks after birth
The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose.
次要结局
- Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy(Up to three months after birth)