Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Feb 27, 2024

Keywords

ClinConnect Summary

The FRENCH-PREMA trial is studying a new way to help doctors understand how much extra fluid premature infants may need when they are facing acute circulatory issues. This study focuses on babies born before 37 weeks of pregnancy. The goal is to find a safe and non-invasive method that can show whether giving extra fluid will really help the baby's heart function or if it might cause harm, like fluid overload. The researchers will use a technique that involves gently pressing on the baby’s abdomen to see how it affects blood flow.

To be part of this study, infants must be less than 37 weeks old and receiving care in a neonatal intensive care unit (NICU). They also need to be prescribed a specific amount of fluid to help their heart function. However, babies with certain serious conditions or recent surgeries may not be eligible. If a baby participates, the doctors will monitor how well this new method works to determine if it can accurately predict the need for extra fluids without putting the baby at risk. This research could help improve care for premature infants in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Premature newborn under 37 weeks of amenorrhea hospitalized in neonatal intensive care
• • Prescription of a 10 to 20ml/kg fluid expansion (crystalloid, blood products or albumin) by the physician in charge, whose goal would be to increase cardiac output (based on clinical, biological and/or echographic criteria).
• Exclusion Criteria:
• • Acute cardiogenic pulmonary edema
• • Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient
• • Non corrected congenital cardiopathy, or inferior to 15 days postoperative. Intra-abdominal hypertension or painful abdominal palpation
• • Abdominal surgery in the last 15 days
• • Supine position contraindicated or deleterious
• • No investigator available to assess ultrasonographic measures
• • Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible