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Sponsored by: |
Fundacion Para La Investigacion Hospital La Fe |
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Information provided by: | Fundacion Para La Investigacion Hospital La Fe |
ClinicalTrials.gov Identifier: | NCT00569608 |
Early discharge of premature infants from the Neonatal Intensive Care Unit will have substantial benefits:
(i) diminish parental stress;
(ii) increase parental - child bonding;
(iii) diminish medical complications derived from prolonged hospitalization;
(iv) reduce cost;
(v) increase number of point of attendance disponible for future patients.
Condition | Intervention |
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Prematurity |
Other: Early Discharge |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit |
Enrollment: | 140 |
Study Start Date: | January 2005 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
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EDA: Experimental
Neonates submitted to the protocol of early discharge.
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Other: Early Discharge
Application of an early discharge protocol from the neonatal intensive care unit.
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SDP: No Intervention
Discharge following the standard protocol of the neonatal intensive care unit.
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Extremely premature infants have to remain for very prolonged time in the hospital. As a consequence, difficulties for establishing an adequate parental-infant bonding arise causing a substantial parental stress manifested as anxiety and depression, and increasing the risk of short and longterm consequences (neglect, abuse, maltreatment, abandonment). In addition, prolonged hospital stay will increase the probability of having medical complications (infections, excessive blood tests or image studies) and the cost of staying. Once the baby has improved sufficiently early discharge may be given independently of the baby's weight. In order to be successful, caregivers, psychologist and parents have to put forward an established protocol to be able to face satisfactorily this situation. We hypothesize that, with an adequate Early Discharge Program, we could substantially reduce length of hospitalization, cost, and reduce parental stress.
Ages Eligible for Study: | 36 Weeks to 42 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | FUNDACION INVESTIGACION HOSPITAL LA FE ( JOSE LUIS CASTELL RIPOLL ) |
Study ID Numbers: | FIHLaFe, AP015/06 |
Study First Received: | December 6, 2007 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00569608 |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Parental stress Early discharge Anxiety Depression Neonatal Intensive Care Unit |
Depression Stress Depressive Disorder |