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Fig. 3 | Trials

Fig. 3

From: Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial

Fig. 3

Participant visit timeline. 1Visit 0 has to be performed at 24–72 h of age. Visit 0 and the screening visit can be performed in the same day starting at 24 h of life. 2 Visit 4, Visit 5, and Visit 6 have to be performed in case the echocardiography highlights a non-hsPDA (Outcome 2) or a persistent hsPDA (Outcome 3) at Visit 3. 3 Follow-up visits (F-up 1, F-up 2, F-up 3, and F-up 4) have to be performed only by patients with an ongoing presentation of Outcome 1 and Outcome 2 at Visit 3. 4 The following parameters will be recorded: ductal size and the left-atrium-to-aortic-root ratio. 5 At Visit 3, in accordance with the echocardiographic evaluation, patients will be differentiated in the following: Outcome 1: patients presenting closed PDA. Outcome 2: patients with non-hsPDA. Outcome 3: patients with persistent hsPDA. 6 Procedures applicable only for patients undergoing the second treatment course of ibuprofen as rescue medication. 7 Laboratory analyses: hematology (including RBC, WBC, platelets, hemoglobin, and hematocrit), creatinine, blood urea nitrogen, AST/GOT, ALT/GPT, total bilirubin, total protein, sodium, potassium, and calcium

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Trials

ISSN: 1745-6215