| CTRI Number |
CTRI/2019/08/020746 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
14/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of phototherapy on calcium level in blood |
|
Scientific Title of Study
|
To measure the effect of phototherapy on serum calcium level in neonates having hyperbilirubinemia in nicu of tertiary care hospital -an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asha Virabhai Patel |
| Designation |
2nd Year Resident Doctor |
| Affiliation |
Government Medical College,Bhavnagar |
| Address |
Department Of Paediatrics,
Government Medical College and Sir T. Hospital,Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866774987 |
| Fax |
|
| Email |
ashapatel998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asha Virabhai Patel |
| Designation |
2nd Year Resident Doctor |
| Affiliation |
Government Medical College,Bhavnagar |
| Address |
Department Of Paediatrics,Government Medical College and Sir T.Hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866774987 |
| Fax |
|
| Email |
ashapatel998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asha Virabhai Patel |
| Designation |
2nd Year Resident Doctor |
| Affiliation |
Government Medical College,Bhavnagar |
| Address |
Department Of Paediatrics,Government Medical College and Sir T.Hospital,Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866774987 |
| Fax |
|
| Email |
ashapatel998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asha Virabhai Patel
Department Of Paediatrics,Government Medical College and Sir T.Hospital,Bhavnagar |
|
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Primary Sponsor
|
| Name |
Asha Virabhai Patel |
| Address |
Department Of Paediatrics,Government Medical College and Sir T.Hospital,Bhavnagar |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAlpa N Parekh |
Sir T.Hospital,Bhavnagar |
Neonatal Intensive Care Unit, Department Of Paediatrics,Sir T Hospital,Near jail road,Bhavnagar
Bhavnagar
GUJARAT |
9428408787
drnileshparekh@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board (human ethics committee) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
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Method of Generating Random Sequence
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Effect of phototherapy in serum calcium level in neonates having hyperbilirubinemia |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hospital stay and discharge |
1 month |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
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. |