| 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
|
|
|
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
|
|
|
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. |