NCT01963065

NICU-HEALTH (Hospital Exposures and Long-Term Health)

Completed Last updated 1 March 2023

What this trial tests

trial in Preterm Birth in 239 participants. Completed in 28 April 2020.

Timeline

1 March 2015

Primary endpoint
28 April 2020

28 April 2020

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Status	Completed
Study type	OBSERVATIONAL
Enrollment	239
Start date	1 March 2015
Primary completion	28 April 2020
Estimated completion	28 April 2020
Sites	1 location across United States

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Under 1, any sex, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the impact of environmental exposures during the NICU hospitalization on preterm infant development. The research team is interested in both chemical and non-chemical exposures. Research studies have shown that babies are exposed to plasticizers (bisphenol A, phthalates) in the NICU. Plasticizers are chemicals that are used to make plastic medical equipment soft and flexible. The research team wants to find out whether NICU-based exposure to chemicals (including common plasticizers) and other non-chemical exposures like stress makes a difference to how they grow and develop.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neonatal intensive care unit phthalate exposure and preterm infant neurobehavioral performance.
   Stroustrup A, Bragg JB, Andra SS, Curtin PC, et al · · 2018 · cited 44× · PMID 29505594 · DOI 10.1371/journal.pone.0193835
2. Sources of clinically significant neonatal intensive care unit phthalate exposure.
   Stroustrup A, Bragg JB, Busgang SA, Andra SS, et al · · 2020 · cited 39× · PMID 30242269 · DOI 10.1038/s41370-018-0069-2
3. Application of growth modeling to assess the impact of hospital-based phthalate exposure on preterm infant growth parameters during the neonatal intensive care unit hospitalization.
   Busgang SA, Spear EA, Andra SS, Narasimhan S, et al · · 2022 · cited 32× · PMID 35944631 · DOI 10.1016/j.scitotenv.2022.157830
4. Clinical validation of the Neonatal Infant Stressor Scale with preterm infant salivary cortisol.
   Pourkaviani S, Zhang X, Spear EA, D'Agostino M, et al · · 2020 · cited 26× · PMID 31847006 · DOI 10.1038/s41390-019-0713-0
5. NICU-based stress response and preterm infant neurobehavior: exploring the critical windows for exposure.
   Zhang X, Spear E, Hsu HL, Gennings C, et al · · 2022 · cited 23× · PMID 35173301 · DOI 10.1038/s41390-022-01983-3
6. The association of prenatal exposure to intensive traffic with early preterm infant neurobehavioral development as reflected by the NICU Network Neurobehavioral Scale (NNNS).
   Zhang X, Spear E, Gennings C, Curtin PC, et al · · 2020 · cited 18× · PMID 32311904 · DOI 10.1016/j.envres.2020.109204
7. 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.
   Stroustrup A, Bragg JB, Spear EA, Aguiar A, et al · · 2019 · cited 13× · PMID 31772104 · DOI 10.1136/bmjopen-2019-032758
8. Environmental influences on child health outcomes: cohorts of individuals born very preterm.
   O'Shea TM, McGrath M, Aschner JL, Lester B, et al · · 2023 · cited 9× · PMID 35948605 · DOI 10.1038/s41390-022-02230-5