Neurodevelopmental Outcomes of Preterm and Term Children

NCT ID: NCT02309697

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-01-31

Brief Summary

This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which will assess development in an examination administered by a trained occupational therapist at Mount Sinai Hospital.

Detailed Description

This research will be completed at Mount Sinai Hospital. All participants will be identified from Mount Sinai Hospital records of infants born at MSH and/or cared for in the Mount Sinai NICU on or after January 1, 2011, at full term or preterm. The study team will contact the parents of eligible potential participants by telephone to explain the study and ask if the parent will consent to their child's participation. If the parent agrees, we will make an appointment for the child to come to Mount Sinai for the evaluation using the Bayley-III. The parents will be mailed the study consent form, a fact sheet with information about the study, and the CBCL to complete before they bring their child to their appointment. Mount Sinai records from the birth hospitalization will be reviewed for the birth history and medical comorbidities. Mount Sinai medical records of the mother's obstetric care will also be accessed to obtain medical history from the pregnancy. If a participating child has received outpatient care at Mount Sinai, the investigators will access their record in Epic to obtain scores from previous developmental assessments and records of medical comorbidities. If they have not attended the Mount Sinai clinic, but have received outpatient care elsewhere, the parents will be asked to provide contact information for their pediatrician, and for permission to obtain their child's records.

Conditions

Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Full Term

Children born at full term on or after Jan 1, 2011

No interventions assigned to this group

PreTerm

Children born preterm on or after Jan 1, 2011

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Born on or after January 1, 2011
• Admitted to the Mount Sinai Hospital for newborn care

Exclusion Criteria

• Non-English speaking

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 42 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemarie Stroustrup, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 12-0332-0001

Identifier Type: -

Identifier Source: org_study_id