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Search / Trial NCT06081075

Newborn Genomics Programme

Launched by LIGGINS INSTITUTE · Oct 10, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

The Newborn Genomics Programme is a clinical trial that aims to use advanced genetic testing to help babies in intensive care units who might have serious health issues. The main focus is on quickly analyzing the DNA of both parents and their newborns to identify any genetic diseases that could be causing health problems. By doing this, the researchers hope to provide more precise and effective care for critically ill infants. They also aim to learn how this genetic testing can be effectively integrated into New Zealand's healthcare system and understand how it impacts families and their experience with healthcare.

To be eligible for the trial, babies must be admitted to the Neonatal Intensive Care Unit (NICU) or Pediatric Intensive Care Unit (PICU) and show signs of a possible genetic condition shortly after being hospitalized. This includes infants who become very ill and do not respond as expected to standard treatments. Participants in the trial can expect to undergo rapid genetic testing, which may lead to faster and more tailored treatment options for their health issues. It's important to note that the trial is currently recruiting participants and will run until March 2026.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Acutely ill inpatient
  • Admitted to NICU or PICU between April 2023 - March 2026
  • Within 1 week of hospitalization or within 1 week of development of abnormal response to standard therapy for an underlying condition
  • Suspected genetic condition, without a clear non-genetic aetiology
  • Exclusion Criteria:
  • Patients whose clinical course is entirely explained by
  • Isolated prematurity
  • Isolated unconjugated hyperbilirubinemia
  • Infection or sepsis with expected response to therapy
  • A previously confirmed genetic diagnosis that explains the clinical condition -
  • Isolated transient neonatal tachypnoea
  • Meconium aspiration syndrome
  • Trauma
  • Inability to source blood and buccal samples for DNA extraction from at least the mother and child

About Liggins Institute

The Liggins Institute is a leading research organization based in New Zealand, dedicated to advancing knowledge in developmental biology and its implications for health. As a prominent clinical trial sponsor, the Institute focuses on translational research that bridges laboratory findings with clinical applications, particularly in the fields of maternal and child health, nutrition, and growth. With a commitment to innovative research methodologies and collaborative partnerships, the Liggins Institute seeks to enhance health outcomes through rigorous clinical trials that inform evidence-based practices and policies. Their multidisciplinary team of experts is dedicated to pioneering discoveries that can significantly impact public health.

Locations

Auckland, , New Zealand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported