Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Admission to NICU for hypoglycemia
研究概览
简要总结
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % of normal newborn babies will have low blood glucose concentrations. It has been demonstrated that treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing the hypoglycemia, and also reduced the rate of NICU admission. investigators study is using dates to asses its effect on hypoglycemia in infants at risk.
详细描述
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. It is a noble practice in Islam, with which the newborn is greeted upon entering into life, usually before milk feeds. It is done by rubbing a softened date on the palate of the new-born just after the birth. The tahneek also exercises the muscles of the mouth and helps with the circulation of blood in the mouth - this may help the baby to be able to suck and take mother's milk. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % but the incidence in babies with risk factors is much greater upto 50 % in infants of diabetic mothers, large and small babies and 66 % in preterm babies. Neonatal hypoglycemia is associated with brain damage, death and developmental delay in later life. Treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycemia, and thus reducing the rate of NICU admission for hypoglycemia. investigators study is using dates to asses its effect on hypoglycemia in infant at risk.
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)
盲法说明
Parents and Statistician are blinded
入排标准
- 年龄范围
- — 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery.
- •Infants of diabetic mothers (any type of diabetes)
- •Late Preterms (34 - 37 weeks' gestation)
- •Low birth weight (< 2.5 kg ) or Small for gestational age
- •Large for gestational age (> 4 kg or > 90th centile on Fenton's growth chart)
排除标准
- •Major congenital abnormality including severe cleft lip and palate.
- •Babies requiring NICU admission immediately after birth
- •Babies less than 34 weeks of age.
- •Babies whose parents refused to consent
研究组 & 干预措施
Tahneek
Infants receiving a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg at 1 hour after birth in the nursery.
干预措施: Tahneek (Other)
CONTROL
Infants at risk for transient neonatal hypoglycemia following standard-of-care.
结局指标
主要结局
Admission to NICU for hypoglycemia
时间窗: first 48 hours of life
infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.
Hypoglycemia
时间窗: first 48 hours of life
infants who meet eligibility criteria and parents have consented will receive a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg within 1 h after birth. Assess glucose level after 1 feed compared to controls with similar risk factors who are not received Tahneek. hypoglycemia defined as any blood glucose concentration \< 2.6 mmol/L.
次要结局
- Breastfeeding(6 months)
- Pain scale(48 hours)
- Hyperglycemia(48 hours)
研究者
Jubara Alallah
Assistant Professor of Pediatrics
King Abdullah International Medical Research Center