Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

• Register: ClinicalTrials.gov
• Last refreshed on: 22 October 2012
• Main ID: NCT01420029
• Date of registration: 17/08/2011
• Primary sponsor: Mount Sinai School of Medicine
• Public title: Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates
• Scientific title: Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates
• Date of first enrolment: August 2011
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01420029
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Jennifer J Bragg, MD

• Name: Jennifer J Bragg, MD

• Name: Annemarie Stroustrup, MD, MPH
• Affiliation: Mount Sinai Hospital Division of Newborn Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Neonates born less than 1500 grams that are admitted to the Mount Sinai Hospital NICU

Exclusion Criteria:

- Chromosomal abnormality or other genetic disorder

- Diagnosis of hypoxic-ischemic encephalopathy

- Inborn error of metabolism

- Congenital renal disease



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Low Birth Weight Neonates

Primary Outcome(s)

Exposure to plasticizers [Time Frame: Length of stay in NICU which averages 8-10 weeks]

Performance on neonatal neurological screening tool [Time Frame: 34 weeks postconceptual age]

Performance on neonatal neurological screening tool [Time Frame: 4 weeks of age]

Secondary Outcome(s)

Extrauterine growth [Time Frame: Weekly during NICU stay with average stay of 8-10 weeks]

Thyroid dysfunction [Time Frame: 4 weeks of age]

Secondary ID(s)

0285-7451

GCO 11-0664

Source(s) of Monetary Support

Please refer to primary and secondary sponsors