跳至主要内容
临床试验/CTRI/2024/04/066495
CTRI/2024/04/066495尚未招募不适用

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

Govind Choudhary1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月15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
80
试验地点
1
主要终点
Incidence of IVH in preterm neonates in different gestational age groups and perinatal risk factors associated with it.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All preterm neonates less than 37 weeks admitted in the Neonatology Unit.

排除标准

  • 1.Lethal congenital malformations.
  • 2.Neonates requiring extensive resuscitation at birth.
  • 3.Death within 12 hours of birth.

结局指标

主要结局

Incidence of IVH in preterm neonates in different gestational age groups and perinatal risk factors associated with it.

时间窗: Birth to Day seven of life

次要结局

  • 1.Morbidity and mortality pattern in different grades of IVH.(2. Duration of hospital stay)

研究者

发起方
Govind Choudhary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Govind Choudhary

Government Medical College and Hospital , aurangabad

研究点 (1)

Loading locations...

相似试验