Related Experiment Video

Updated: Dec 2, 2025

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

87.1K

Parental perspectives long term after neonatal clinical trial participation: a survey

Thomas Salaets1, Emilie Lavrysen2, Anne Smits2

  • 1Department of Development and Regeneration, KULeuven, Leuven, Belgium. thomas.salaets@kuleuven.be.

Trials
|November 3, 2020
PubMed

Insights

Parents generally reported positive long-term experiences and satisfaction after their neonate participated in clinical trials. However, communication and follow-up in neonatal drug trials need improvement.

Area of Science:

  • Neonatal research
  • Clinical trial ethics
  • Parental perspectives

Background:

  • Recruiting neonates for clinical trials presents ethical challenges, yet is vital for advancing neonatal care.
  • Limited data exists on long-term parental experiences and emotions after infant participation in clinical trials.
  • This study aimed to evaluate parental perspectives long-term post-neonatal interventional drug trial participation.

Purpose of the Study:

  • To assess parental experiences and emotions long-term after their neonate's participation in an interventional drug trial.
  • To understand parental contentment, perceived trial impact on care and health, and emotional consequences.
  • To gauge parental awareness of clinical trial characteristics.

Main Methods:

  • Survey distributed to parents of former neonatal interventional drug trial participants (3-13 years post-trial).
  • Assessed parental satisfaction, perceived trial influence, emotional impact, and understanding of trial characteristics using Likert scales.
  • Collected data from 123 parents, representing 52% of eligible families.

Main Results:

  • High parental contentment with overall trial participation (median 5.00) reported by those recalling it.
  • Most parents perceived no significant influence of the trial on their child's care or health.
  • While most reported satisfaction and pride, a minority experienced anxiety, stress, or guilt; 27% were unaware of typical trial characteristics.

Conclusions:

  • Parents generally report positive long-term experiences and minimal emotional distress after neonatal clinical trial participation.
  • Effective communication regarding trial concepts and characteristics during consent and follow-up is crucial for improving neonatal clinical trials.
  • Future research should focus on enhancing parental understanding and support throughout the trial process.
Abstract

Keywords:
Clinical bio-ethicsNeonatal clinical trials

More Related Videos

Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling07:11

Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling

Published on: February 5, 2019

9.4K
A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting14:43

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

12.4K

Related Concept Videos

Longitudinal Research02:20

Longitudinal Research

Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...
12.9K
Longitudinal Studies01:26

Longitudinal Studies

Longitudinal studies are also widely used in other medical and social science fields. For instance, in cardiovascular research, they can monitor patients' health over decades to identify risk factors for heart disease, such as high cholesterol or smoking, and evaluate the long-term effectiveness of preventive measures. Similarly, in mental health studies, researchers might follow individuals from adolescence into adulthood to understand the development and progression of conditions like...
358
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.3K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.0K
Parental Care00:55

Parental Care

Many animals exhibit parental care behavior, including feeding, grooming, and protecting young offspring. Parental care is universal in mammals and birds, which often have young that are born relatively helpless. Several species of insects and fish, as well as some amphibians, also care for their young.
12.3K
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
66