Prophylactic IV Paracetamol in Extremely Premature Infants
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Presence of patent ductus arteriosus
研究概览
简要总结
Purpose of the research Everyone is born with an opening between the chambers of the heart, called a ductus arteriosus. In most people, it closes on its own, but in infants born at less than 30 weeks or less than 1250 grams, there is a higher chance that it won't close on its own. So we give drugs to make it more likely that it closes. There are different medications that can do that, so we want to compare them to find which has the best effect.
Type of Research Intervention The drug will be given at age of 6 hours, then every 6 hours through IV.
Participant selection We are inviting suitable children with gestational age less than 30 weeks or birth weight less than 1250 grams.
Voluntary Participation Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change. If you choose not to participate in this research project, you will offered the treatment that is routinely offered in this hospital for the disease, and we will tell you more about it later. You may change your mind later and stop participating even if you agreed earlier.
The drug we want to give is paracetamol, it is a safe drug that has been tested on children of this age and proved to be safe. It has also been tested for this disease and shown to be effective. Some participants in the research will not be given this drug. Instead, they will be given Indomethacin, which is the most commonly used to prevent Ductus Arteriosus.
Procedures and Protocol
To compare the different medications, you will be randomly chosen as to whether you will receive which drug.
Standardly, different hospitals offer different treatments for the prevention of PDA. Some offer paracetamol, some offer indomethacin and some offer nothing. We will compare these options.
An echocardiography (imaging of the heart) will be done after 72 hours to check if the opening in the heart closed. In addition, close follow-up and attention will be given to check for its effects on the body. Lastly, blood tests will be taken at 24 hours, 72 hours, and after completing the course. They will measure liver enzymes in addition to others. A long-term follow-up will be done at 6 months.
B. Description of the Process
Duration The duration of the research will be for 6 months, but you will be asked to come back to the hospital after discharge only once after the 6 months.
Side Effects The medication is very unlikely to cause any side effects. However, the infant will be followed up closely to make sure that he doesn't develop any, and if he dose, we deal with it the right way and prevent it from harming the infant.
Risks By participating in this research, it is possible that your disease will not get better and that the new medicine won't work even as well as the old one. In this case, we have other medications that can be given to close it and solve the problem.
Benefits Your participation in this research will be of great benefit to the people and to other preterm infants. It will help us find out which medication is the best and give it to the upcoming newborns that are born early, like your child. Improving their lives.
Confidentiality The information that we collect from this research will remain confidential. Your child's name, condition, or research participation won't be discussed or released. The data will be stored in a safe place that isn't accessible except by a few people, then his data will be included among all others without mentioning his name or anything that may be used to identify him.
Sharing the Results After collection and analyzing the data, encoding it and removing all confidential information, the data of all the participants will be assembled into a scientific article and published in a scientific journal to help and reach more people. You will also be notified of the research outcomes before the paper.
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected.
Alternatives to Participating
If you do not wish to take part in the research, you will be provided with the established standard treatment available at the center/institute/hospital. People who have malaria are given
详细描述
Detailed Description This research project, titled "Prophylactic IV paracetamol in extremely premature infants: A Palestinian-Based Study," aims to investigate the efficacy of prophylactic intravenous paracetamol in preventing Patent Ductus Arteriosus (PDA) in extremely premature infants born at less than 30 weeks of gestation or with a birth weight below 1250 grams. The study will be conducted in Palestine Medical Complex, Al Makassed,and Al Ahli hospitals.
Background:
Patent Ductus Arteriosus (PDA) is a common cardiovascular complication in premature and low birth-weight infants. While it typically closes spontaneously in full-term infants, it often remains open in premature infants, leading to hemodynamically significant PDA (HSPDA) with potential cardiopulmonary distress. Current pharmacological interventions to promote PDA closure include NSAIDs like indomethacin and ibuprofen, which carry risks of adverse effects such as renal impairment and gastrointestinal complications. Paracetamol has emerged as a potential alternative due to its cyclooxygenase (COX) inhibitory effects and a potentially safer profile. This study seeks to evaluate the effectiveness of prophylactic IV paracetamol in reducing the incidence of PDA and its associated complications in this vulnerable population.
Study Design:
This is a prospective, double blinded randomized controlled clinical trial. The study will compare the incidence of PDA requiring medical or surgical intervention, as well as various short-term and long-term neonatal outcomes, between a group receiving prophylactic IV paracetamol and a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational ages of <30 weeks or birth weight below 1250 gm
- •inborn babies
- •authorization to perform the study signed by one of the parents after receiving enough information about the condition
排除标准
- •Outborn babies
- •The presence of a significant birth defect or a congenital anomaly
- •Clinical instability that can lead to rapid death
研究组 & 干预措施
Given prophylactic IV paracetamol
The patients are given IV prophylactic paracetamol within the first 24 hours of life, first dose at the age of 6 hours, (15mg/kg/dose Q6hrs daily for five days).
干预措施: Paracetamol (drug) (Drug)
结局指标
主要结局
Presence of patent ductus arteriosus
时间窗: 72 hours
The primary outcome is the presence of patent ductus arteriosus (diagnosed by echocardiography)
次要结局
- mortality(Within 1 month of birth)
- bronchopulmonary dysplasia(36 weeks corrected gestational age)
- severity of respiratory distress syndrome(Within 1 month of birth)
- Definitive sepsis(Within 1 month of birth)
- Massive pulmonary hemorrhage(Within 1 month of birth)
- Intraventricular hemorrhage (grade III or IV)(Within 1 month of birth)
- oxygen requirements at 28 days postnatal age(28 days after birth)
- necrotizing enterocolitis (stage 2 or 3)(Within 1 month of birth)
- Retinopathy of prematurity(4-9 weeks after birth)
- Liver enzymes(at 24 hours, and at 72 hours of birth, in addition to after completion of the paracetamol course)