Related Experiment Video

Updated: Jul 12, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
19:15

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

Prophylactic ibuprofen in premature infants: a multicentre, randomised, double-blind, placebo-controlled trial

Bart Van Overmeire1, Karel Allegaert, Alexandra Casaer

  • 1Antwerp University Hospital, Edegem, Belgium. bart.van.overmeire@uza.be

Lancet (London, England)
|November 30, 2004
PubMed

Insights

Early ibuprofen prophylaxis in preterm infants does not prevent severe intraventricular hemorrhage but effectively closes the patent ductus arteriosus. This study highlights ibuprofen

Area of Science:

  • Neonatal Medicine
  • Pediatric Pharmacology
  • Clinical Trials

Background:

  • Patent ductus arteriosus (PDA) and severe intraventricular hemorrhage (IVH) are critical concerns in low-birthweight infants.
  • Indomethacin prophylaxis has shown efficacy in reducing PDA and IVH, prompting investigation into alternative treatments.
  • Ibuprofen's distinct effects on regional circulations necessitate a direct comparison with placebo for prophylactic use.

Purpose of the Study:

  • To evaluate the efficacy of early ibuprofen administration in preventing severe IVH in preterm infants.
  • To assess the effectiveness of early ibuprofen in reducing the occurrence of PDA.
  • To identify potential adverse effects associated with prophylactic ibuprofen use.

Main Methods:

  • A double-blind, multicenter trial involving 415 low-birthweight infants (gestational age <31 weeks) within 6 hours of birth.
  • Infants were randomly assigned to receive either intravenous ibuprofen-lysine or a placebo.
  • Primary outcome was severe IVH; secondary outcomes included PDA and adverse effects. Intention-to-treat analysis was performed.

Main Results:

  • Severe IVH occurred in 8% of the ibuprofen group and 9% of the placebo group (Relative Risk 0.97).
  • PDA closure by day 3 was significantly higher in the ibuprofen group (84%) compared to placebo (60%) (Relative Risk 1.40).
  • Lower urine production and higher serum creatinine levels were observed on days 1 and 3, respectively, in the ibuprofen group.

Conclusions:

  • Early ibuprofen prophylaxis does not significantly reduce the incidence of severe intraventricular hemorrhage in preterm infants.
  • Prophylactic ibuprofen administration effectively decreases the occurrence of patent ductus arteriosus in this population.
  • While generally safe, ibuprofen may transiently affect renal function in neonates.
Abstract

More Related Videos

Enhancing the Development and Growth of Infant Cerebral Palsy Rats Using Selective Spinal Manipulations05:04

Enhancing the Development and Growth of Infant Cerebral Palsy Rats Using Selective Spinal Manipulations

Published on: February 2, 2024

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)04:11

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)

Published on: June 9, 2026

Related Concept Videos

Blind Procedures02:07

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...
Controls in Experiments01:13

Controls in Experiments

When conducting an experiment, it is crucial to have control to reduce bias and accurately measure the dependent variables. It also marks the results more reliable. Controls are elements in an experiment that have the same characteristics as the treatment groups but are not affected by the independent variable. By sorting these data into control and experimental conditions, the relationship between the dependent and independent variables can be drawn. A randomized experiment always includes a...
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...