Cohort profile: the Neonatal Intensive Care Unit Hospital Exposures and Long-Term Health (NICU-HEALTH) cohort, a prospective preterm birth cohort in New York City

BMJ Open. 2019 Nov 25;9(11):e032758. doi: 10.1136/bmjopen-2019-032758.

Abstract

Purpose: The Neonatal Intensive Care Unit Hospital Exposures and Long-Term Health (NICU-HEALTH) longitudinal preterm birth cohort studies the impact of the NICU exposome on early-life development. NICU-HEALTH collects multiple biospecimens, complex observational and survey data and comprehensive multisystem outcome assessments to allow measurement of the impact of modifiable environmental exposures during the preterm period on neurodevelopmental, pulmonary and growth outcomes.

Participants: Moderately preterm infants without genetic or congenital anomalies and their mothers are recruited from an urban academic medical centre level IV NICU in New York City, New York, USA. Recruitment began in 2011 and continues through multiple enrolment phases to the present with goal enrolment of 400 infants. Follow-up includes daily data collection throughout the NICU stay and six follow-up visits in the first 2 years. Study retention is 77% to date, with the oldest patients turning age 8 in 2019.

Findings to date: NICU-HEALTH has already contributed significantly to our understanding of phthalate exposure in the NICU. Phase I produced the first evidence of the clinical impact of phthalate exposure in the NICU population. Further study identified specific sources of exposure to clinically relevant phthalate mixtures in the NICU.

Future plans: Follow-up from age 3 to 12 is co-ordinated through integration with the Environmental Influences on Child Health Outcomes (ECHO) programme. The NICU-HEALTH cohort will generate a wealth of biomarker, clinical and outcome data from which future studies of the impact of early-life chemical and non-chemical environmental exposures can benefit. Findings from study of this cohort and other collaborating environmental health cohorts will likely translate into improvements in the hospital environment for infant development.

Trial registration numbers: This observational cohort is registered with ClinicalTrials.gov (NCT01420029 and NCT01963065).

Keywords: NICU; children’s environmental health; longitudinal birth cohort; neonatal intensive care unit; prematurity.

Publication types

  • Observational Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child Development
  • Developmental Disabilities / etiology
  • Environmental Exposure / adverse effects*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature*
  • Infant, Very Low Birth Weight*
  • Intensive Care Units, Neonatal*
  • Male
  • New York City
  • Phthalic Acids / adverse effects*
  • Prospective Studies
  • Research Design

Substances

  • Phthalic Acids
  • phthalic acid

Associated data

  • ClinicalTrials.gov/NCT01420029
  • ClinicalTrials.gov/NCT01963065