Clinical trial NCT02309697: Neurodevelopmental Outcomes of Preterm and Term Children
Official title: Neurodevelopmental Outcomes of Preterm and Term Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Development
Keywords: Development
Assessments
Premature birth
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 children born on or after January 1, 2011 at Mount Sinai or admitted to the Mount Sinai Hospital for newborn care.

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.

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

Primary outcomes:
measure: Child Behavior Checklist (CBCL)
timeFrame: day 1
Secondary outcomes:
measure: Bayley Scales of Development III (BayleyIII)
timeFrame: day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annemarie Stroustrup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: