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

NCT01963065 | Completed

• 2 other identifiers: GCO 12-03321K23ES022268-01
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth

Keywords

Children's environmental health; Preterm birth; Newborns; Bisphenol A; BPA; Phthalates; Metals exposure; Very low birth weight; NICU; Stress

Outcome Measures

Primary Outcomes (1)

• NICU Network Neurobehavioral Scale

  Performance on a scale of newborn neurodevelopment designed both for use in newborns exposed to toxins in utero and for evaluation of infants born preterm

  at 34-42 weeks postmenstrual age

Secondary Outcomes (1)

• Dense-array electroencephalogram

  at 34-42 weeks postmenstrual age

Study Arms (1)

Moderately pre-term infants and their mothers

cohort of moderately pre-term infants and their mothers

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates born 28-0/7 through 32-6/7 weeks gestation admitted to the Mount Sinai NICU are be eligible for enrollment.

You may qualify if:

• Birth at Mount Sinai Hospital
• Gestational age at birth 28-0/7 through 32-6/7 weeks

You may not qualify if:

• Birth at an outside hospital
• Chromosomal abnormality or other genetic disorder
• Concern for hypoxic-ischemic encephalopathy
• Inborn error of metabolism
• Congenital renal disease
• Intestinal obstruction
• Major congenital anomaly

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (4)

• Stroustrup A, Bragg JB, Busgang SA, Andra SS, Curtin P, Spear EA, Just AC, Arora M, Gennings C. Sources of clinically significant neonatal intensive care unit phthalate exposure. J Expo Sci Environ Epidemiol. 2020 Jan;30(1):137-148. doi: 10.1038/s41370-018-0069-2. Epub 2018 Sep 21.

  PMID: 30242269 BACKGROUND

• Stroustrup A, Bragg JB, Andra SS, Curtin PC, Spear EA, Sison DB, Just AC, Arora M, Gennings C. Neonatal intensive care unit phthalate exposure and preterm infant neurobehavioral performance. PLoS One. 2018 Mar 5;13(3):e0193835. doi: 10.1371/journal.pone.0193835. eCollection 2018.

  PMID: 29505594 BACKGROUND

• Stroustrup A, Teitelbaum SL, Aschner JL. The Value of Preterm Infant Environmental Health Cohorts: The Canary in the Coal Mine. JAMA Pediatr. 2017 Dec 1;171(12):1139-1140. doi: 10.1001/jamapediatrics.2017.3230. No abstract available.

  PMID: 29059271 BACKGROUND

• Stroustrup A, Bragg JB, Spear EA, Aguiar A, Zimmerman E, Isler JR, Busgang SA, Curtin PC, Gennings C, Andra SS, Arora M. 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.

  PMID: 31772104 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA - samples retained, with potential for extraction of DNA from at least one fo the types of samples retained (e.g., frozen tissue, whole blood)

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Annemarie Stroustrup, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 16, 2013
• Study Start: March 1, 2015
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

US (1)