Related Experiment Video

Updated: Dec 13, 2025

Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings
04:16

Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings

Published on: February 7, 2025

771

Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised

Maximiliane Verfürden1, Katie Harron2, John Jerrim3

  • 1Great Ormond Street Institute of Child Health, University College London, London, UK m.verfuerden@ucl.ac.uk.

BMJ Open
|July 26, 2020
PubMed

Insights

This study links infant formula trials to educational records to assess long-term cognitive effects. It provides unbiased insights into infant nutrition

Area of Science:

  • Pediatric Nutrition
  • Cognitive Development
  • Educational Psychology

Background:

  • Infant nutrition significantly impacts long-term cognitive development.
  • Existing clinical trials often lack sufficient long-term follow-up and suffer from high attrition rates, leading to biased results.
  • Educational performance serves as a reliable, unbiased marker for cognitive function in children.

Purpose of the Study:

  • To evaluate the long-term educational performance of children randomized to nutritionally modified infant formula versus standard formula.
  • To provide unbiased, long-term follow-up data on the effects of infant nutrition on cognitive outcomes.
  • To investigate the impact of infant formula interventions on academic achievement and special educational needs support.

Main Methods:

  • Utilized data from 1923 participants across seven randomized infant formula trials.
  • Linked trial data to the English National Pupil Database (NPD) for educational records.
  • Analyzed primary outcomes (Math exam z-scores at age 16) and secondary outcomes (English exam z-scores at ages 11 and 16, and special educational needs support).

Main Results:

  • The study is designed to provide new insights into the effect of infant nutrition on school achievement.
  • Primary analysis will focus on differences in mathematics exam z-scores at age 16.
  • Secondary analyses will examine English exam performance and the likelihood of receiving special educational needs support.

Conclusions:

  • This research addresses the critical need for unbiased, long-term follow-up in infant nutrition studies.
  • Linking administrative education records to infant trials offers a robust method for assessing long-term cognitive impacts.
  • Findings will contribute valuable evidence for parents, policymakers, and the scientific community regarding infant feeding practices.
Abstract

Keywords:
clinical trialsnutrition & dieteticspaediatric neurologypublic health

More Related Videos

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.0K
Author Spotlight: Studying the Impact of Maternal Dietary Deficiencies on Long-Term Offspring Health Outcomes03:19

Author Spotlight: Studying the Impact of Maternal Dietary Deficiencies on Long-Term Offspring Health Outcomes

Published on: June 28, 2024

662

Related Concept Videos

Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
110
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
153
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,...
71
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
178
Environmental Influences on Intelligence01:29

Environmental Influences on Intelligence

Despite the strong genetic influence on traits like intelligence, environmental factors significantly shape outcomes. For example, while over 90% of height variation is due to genetic differences, environmental factors such as nutrition also have a notable impact. Similarly, for intelligence, changes in a child's surroundings can significantly alter their IQ. Research shows that enriched environments boost children's academic success and help them develop key cognitive skills. Children...
752
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Body: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...
132