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Completed
NCT00310869
Adolescents Born Preterm; Nurtured Beginnings
Conditions: Preterm Birth
Sex: All
Ages: 14 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 46
Sponsor: Boston Children's Hospital
Location: Children's Hospital Boston Boston Massachusetts
Summary
This research study is a long-term follow-up to an earlier study of developmental care. For that study, high risk preterm newborns were randomly assigned to a standard care group, which received the standard care offered in the Newborn Intensive Care Unit (NICU) at the time, or to an experimental group, which received regular behavioral observations to determine if changes in their environment or care were needed. The purpose of the current study is to assess the functioning of these infants again, now that they are adolescents and to compare the groups to determine if the developmental care used in the original study is effective long-term.
Eligibility Criteria
Inclusion Criteria (when recruited as newborns):
* Gestational age at birth ≤ 28 weeks
* Birth weight ≤ 1250 grams
* In need of mechanical ventilation for at least 24 of the first 48 hours
* Singleton
* Born at the study hospital
* Free of known genetic or acquired infections or abnormalities
* Mother living in the vicinity of the study hospital
* Mother comfortable with English
* Mother free of major physical and mental illnesses
Exclusion Criteria (when recruited as newborns):
* Gestational age at birth \> 28 weeks
* Birth weight \> 1250 grams
* No mechanical ventilation for the first 48 hours
* Multiple (twin, triplet)
* Not born at the study hospital
* Genetic or acquired infections or abnormalities
* Mother lived outside the vicinity of the study hospital
* Mother was not comfortable with English
* Mother had major physical and/or mental illnesses
Source: ClinicalTrials.gov (NCT00310869). StuddyBuddy aggregates publicly available trial information.