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Paediatrics
Cohort profile
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
  1. Annemarie Stroustrup1,2,
  2. Jennifer B Bragg1,
  3. Emily A Spear1,
  4. Andrea Aguiar3,
  5. Emily Zimmerman4,
  6. Joseph R Isler5,
  7. Stefanie A Busgang2,
  8. Paul C Curtin2,
  9. Chris Gennings2,
  10. Syam S Andra2,
  11. Manish Arora2
  1. 1Pediatrics, Icahn School of Medicine at Mount Sinai, New York City, New York, USA
  2. 2Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York City, New York, USA
  3. 3Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA
  4. 4Communication Sciences and Disorders, Northeastern University, Boston, Massachusetts, USA
  5. 5Pediatrics, Columbia University, New York City, New York, USA
  1. Correspondence to Dr Annemarie Stroustrup; annemarie.stroustrup{at}mssm.edu

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).

  • NICU
  • neonatal intensive care unit
  • children’s environmental health
  • prematurity
  • longitudinal birth cohort

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-032758

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    Footnotes

    • Collaborators Requests for collaboration, either sample analyses or data analyses using the NICU-HEALTH data repository, can be made in writing to the principal investigator once the primary analyses planned have been completed. The NICU-HEALTH study management group will evaluate the request and if written approval is provided, a prespecified analytical plan will be requested.

    • Contributors AS and JBB designed the study, facilitated and co-ordinated the samples and data collection. AS, JBB and EAS obtained the clinical data. AS, JBB, AA, EZ and JRI designed and performed clinical phenotyping. SAB, PCC and CG designed and performed the statistical analysis plan. SSA and MA designed and conducted the environmental chemical analysis plan. AS drafted this manuscript, and all authors made significant contributions to this manuscript and have read and approved the final version of it.

    • Funding NICU-HEALTH is supported by the National Institutes of Health for the Environmental Influences on Child Health Outcomes (ECHO) programme through co-operative agreement UH3OD023320. Additional past funding for this cohort came through pilot grants from the Passport Foundation and the Mount Sinai Children’s Environmental Health Center, a National Institute of Environmental Health Sciences (NIEHS) mentored award K23ES022268 to Dr. Stroustrup, NIEHS centre grant P30ES023515 and the primary phase of the ECHO programme UG3OD023320. The study funders did not and will not have a role in or authority over study design; collection, management, analysis and interpretation of data; writing of reports or the decisions to submit reports for publication.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval This study has been continuously approved by the Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects since 2011 (GCO 11-0664 and 12 -0332).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.