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临床试验/CTRI/2019/08/020746
CTRI/2019/08/020746尚未招募不适用

To measure the effect of phototherapy on serum calcium level in neonates having hyperbilirubinemia in nicu of tertiary care hospital -an observational study

Asha Virabhai Patel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Effect of phototherapy in serum calcium level in neonates having hyperbilirubinemia

研究概览

简要总结

Jaundice is an important problem in the first week of life.it is a cause of concern for the physician and source of anxiety for the parents. High bilirubin level may be toxic to the developing central nervous system and may cause neurological impairment even in term newborns. Nearly 60% of term new born become visibly jaundiced in the first week of life . In most cases, it is benign and no intervention is required. Approximately 5-10% of them have clinically significant hyperbilirubinemia in whom the use of phototherapy becomes mandatory. Jaundice is attributable to physiological immaturity of neonates to handle increased bilirubin production. Visible jaundice usually appear between 24-72 hours of age. Basic pathophysiology of jaundice is same in term and preterm neonates,but premature babies are at a higher risk of developing hyperbilirubinemia. The commonly known side effect of the phototherapy are loose stool,hyperthermia,dehydration  fluid loss , skin burn, photo retinitis, low platelet count, increased red cell osmotic fragility, bronze baby syndrome, riboflavin deficiency and DNA damage. A lesser known side effect , but potential complication of phototherapy is hypocalcemia(hunter,2004). Neonatal hypocalcemia is defined as total serum calcium concentration of <7 mg/do or ionized calcium concentration of <4 mg/DL(<1mol/L). Ionized calcium is crucial for many biochemical processes , including blood coagulation, neuromuscular excitability, cell membrane integrity and function, and cellular enzymatic and secretory activity.

Hypocalcemia increases cellular permeability to sodium ions and increases cell membrane excitability. The sign are usually non specific like apnea , seizures, jitterness, increased extensor tone , tonus , hyperreflexia and stride( laryngospasm)

. phototherapy inhibits pineal secretion of melatonin which blocks the effect of cortisol on bone calcium.cortisol unchecked exerts a direct hypocalcemic effect and increases bone uptake of calcium as well.neonates requiring phototherapy are at a higher risk of developing hypocalcemia.

Although morbidity widely varies,serioud complications can arise from hypocalcemia.understanding the pathophysiology and treatment options for phototherapy induce hypocalcemia is important because significant morbidity and mortality are possible.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Full term neonates Unconjugated Hyperbilirubinemia Bilirubin level from 15 to 20mg/do and needed treatment with phototherapy according to the guidelines of the American academy of Paediatrics.

排除标准

  • With onset of jaundice within 24hrs of age With perinatal asphyxia(Apgar<4at 1 minute of birth) Whose mother had history of taking Anticonvulsants Who had exchange transfusion With sepsis With jaundice having hypocalcemia prior to the start of phototherapy Babies born with apparent major congenital anomalies Neonates with conjugated hyperbilirubinemia Baby of diabetic mother.

结局指标

主要结局

Effect of phototherapy in serum calcium level in neonates having hyperbilirubinemia

时间窗: 1 year

次要结局

  • Hospital stay and discharge(1 month)

研究者

发起方
Asha Virabhai Patel
申办方类型
Government medical college

研究点 (1)

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