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Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)

RecruitingNAAges 1 Week - 8 WeeksAllAnn & Robert H Lurie Children's Hospital of Chica…
NCT07372898 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments. Additionally, their parents are at higher risk for adverse mental health outcomes. Early relationships are essential to healthy growth and development in all children. Relationships between parents and infants born with a congenital defect are negatively impacted by separation due to hospitalization; parental and infant stress exposures; and alterations in infant behavior and parental mental health. Benefits of H-HOPE intervention on infant neurodevelopment outcomes have been observed in healthy and at-risk term and preterm infant populations but never evaluated in infants with congenital defects. The purpose of this study is to examine impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention versus standa

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📋 Eligibility rules (as published)
Inclusion criteria: * Infants and one or both of their parents, born with a congenital defect and requiring major surgery during the neonatal period, including congenital heart disease. * At the time of H-HOPE initiation, infants must be \<48 weeks post-menstrual age (PMA), clinically stable (no vital sign instability during routine nursing care) on respiratory support \< a nasal cannula at 2 liters per minute, and off all intravenous (IV) pain medications. Exclusion criteria: * Infants born at \<34 weeks gestation, * Infants born with congenital defects involving the nervous system (i.e., spina bifida, congenital hydrocephalus), * Infants with genetic syndromes, * Infants with a history of Extracorporeal Membrane Oxygenation, * Infants with a history of mechanical ventilation lasting 30 or more days, or * Infants that are wards of the state.
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What it tests

  • H-HOPE
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Where

1 site
Ann & Robert H Lurie Children's Hospital
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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