Prophylactic IV Paracetamol in Extremely Premature Infants

NCT07067177 | Enrolling By Invitation Phase 2

• 1 other identifier: Ref#: Re11-06-024
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Patent Ductus Arteriosus in Preterm Infants; Patent Ductus Arteriosus After Premature Birth; Patent Ductus Arteriosus (PDA); Patent Ductus Arteriosus in Premature Infants

Keywords

Paracetamol prophylaxis; Paracetamol; Extremely premature infants; Extremely Premature; Neonates; Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• Presence of patent ductus arteriosus

  The primary outcome is the presence of patent ductus arteriosus (diagnosed by echocardiography)

  72 hours

Secondary Outcomes (10)

• 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

Study Arms (2)

Given prophylactic IV paracetamol

ACTIVE COMPARATOR

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).

Drug: Paracetamol (drug)

No prophylactic paracetamol is given

NO INTERVENTION

No prophylactic paracetamol or placebo are given.

Interventions

Paracetamol (drug) DRUG

IV prophylactic paracetamol will be given prior to detection of PDA starting from 6 hours of age. It will be used to measure wethere this intervention reduces the risk of having persistant PDA, HsPDA, or any of their complications.

Also known as: Acetaminophen, IV paracetamol

Given prophylactic IV paracetamol

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Outborn babies
• The presence of a significant birth defect or a congenital anomaly
• Clinical instability that can lead to rapid death

Sponsors & Collaborators

• Al-Quds University: lead

Study Sites (3)

Makassed

East Jerusalem, Palestinian Territories

Location

Al Ahli Hospital

Hebron, Palestinian Territories

Location

Palestine Medical Complex

Ramallah, Palestinian Territories

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hadeel Atout, MD

  Palestine Medical Complex and Al-Quds University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 20, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-04

Locations

PA (3)