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CTRI Number  CTRI/2024/04/066495 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Associations, Causes and Outcomes of Intraventricular hemorrhage in preterm neonates 
Scientific Title of Study   Epidemiology, Risk factors, Clinical profile and Outcomes of Intraventricular hemorrhage in preterm neonates admitted in NICU in a low-middle income country-A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Govind Choudhary 
Designation  Senior Resident, DM Neonatology 
Affiliation  Government Medical College and Hospital , aurangabad 
Address  Department of Neonatology 2nd Floor Government Medical College and Hospital, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  8828139444  
Fax    
Email  g.c.medi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr LS Deshmukh 
Designation  Professor and Head of the Department 
Affiliation  Government Medical College and Hospital, Aurangabad 
Address  Department of Neonatology 2nd floor Government Medical College and Hospital, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9822478275  
Fax    
Email  deshmukhls@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr LS Deshmukh 
Designation  Professor and Head of the Department 
Affiliation  Government Medical College and Hospital, Aurangabad 
Address  Department of Neonatology 2nd floor Government Medical College and Hospital, Aurangabad


MAHARASHTRA
431001
India 
Phone  9822478275  
Fax    
Email  deshmukhls@yahoo.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Aurangabad, PIN- 431001, State: Maharashtra, INDIA 
 
Primary Sponsor  
Name  Govind Choudhary 
Address  Department Of Neonatology Government Medical College and Hospital, Aurangabad 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Govind Choudhary  Government Medical College and Hospital, Aurangabad  Department of Neonatology Government Medical College and Hospital, Aurangabad
Aurangabad
MAHARASHTRA 
8828139444

g.c.medi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-GMCA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P523||Unspecified intraventricular (nontraumatic) hemorrhage of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All preterm neonates less than 37 weeks admitted in the Neonatology Unit.

 
 
ExclusionCriteria 
Details  1.Lethal congenital malformations.
2.Neonates requiring extensive resuscitation at birth.
3.Death within 12 hours of birth. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of IVH in preterm neonates in different gestational age groups and perinatal risk factors associated with it.  Birth to Day seven of life 
 
Secondary Outcome  
Outcome  TimePoints 
1.Morbidity and mortality pattern in different grades of IVH.
2. Duration of hospital stay
3. Respiratory support invasive and noninvasive required
 
Birth to death in NICU or discharge from the hospital. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Intraventricular hemorrhage (IVH) is one of the leading causes of mortality and disability in premature newborns, leading to motor disorder, paralysis, long-term cognitive impairment, mental retardation, and seizure.

Several studies conducted worldwide during the past five years have reported the incidence rate of IVH to be between 20%-40% in preterm infants. The frequency of IVH is 10–20% in preterms born before the 30th gestational week, and rates of serious IVH increase up to 35–45% in babies born with a birth weight below 750 grams. Post-hemorrhagic ventricular dilatation develops in approximately half of these babies and a permanent ventriculo-peritoneal (VP) shunt is needed in 20–40%.

The incidence of IVH has decreased significantly over the last decade due to the global improvements in neonatal care, which seems to be because of improving practices such as the use of antenatal corticosteroids, practical resuscitation skills, appropriate handling of infants, better infrastructure, and the judicious use of ventilation. However, an increase in preterm delivery resulting from the enhancement of assisted reproductive technology-mediated pregnancy has highly affected the incidence rate of IVH.

IVH is the extension of hemorrhage into the lateral, third, and fourth ventricles and is less prevalent among full-term neonates because they have a more complex germinal matrix. The risk factors for GMH(Germinal Matrix Hemorrhage)-IVH are acute inflammation of the placenta, increased number of leukocytes in the first 72 h after birth, increased white blood cell count, and masculinity. The other risk factors for IVH include prematurity, low birthweight (LBW), long term mechanical ventilation, low 5-minute Apgar score, hypoxia-induced damage, hypothermic ischemia, Pneumothorax, and thrombocytopenia, antenatal maternal hemorrhage, maternal infection/ inflammation, sepsis, hypotension, hypoxia, hypercapnia, seizures, patent ductus arteriosus (PDA), infection, and respiratory distress, genetic factors.

About 15-20% of premature newborns are exposed to IVH, and this is associated with serious complications and mortality in the absence of timely diagnosis and intervention. Since preterm newborns’ brain is sensitive to blood pressure fluctuations, routine care measures seems to be essential among this population

Recently, a series of measures (namely cesarean delivery, delayed cord clamping, minimal handling of infants, avoiding head down position, midline head positioning for 72h, keeping head of the bed up at 15 - 20 degrees, slow infusion of fluids, and antenatal corticosteroids for IVH prevention) have been adopted in different NICUs.

Given the high complication of IVH and its high mortality rate in preterm newborns, and the lack of sufficient research in this regard, the present study aimed to determine the frequency of IVH and its risk factors in the premature neonates admitted to NICU at our Govt. run tertiary care center. 

 
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