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Tracking Information | |||||
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First Received Date † | December 6, 2007 | ||||
Last Updated Date | December 6, 2007 | ||||
Start Date † | January 2005 | ||||
Current Primary Outcome Measures † |
Reduction in the length of hospitalization. [ Time Frame: Days of hospitalization ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Early Hospital Discharge Program in Neonatology | ||||
Official Title † | Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Supportive Care, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study | ||||
Condition † | Prematurity | ||||
Intervention † | Other: Early Discharge | ||||
Study Arms / Comparison Groups |
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Publications * | Sáenz P, Cerdá M, Díaz JL, Yi P, Gorba M, Boronat N, Barreto P, Vento M. Psychological stress of parents of preterm infants enrolled in an early discharge programme from the neonatal intensive care unit: a prospective randomised trial. Arch Dis Child Fetal Neonatal Ed. 2009 Mar;94(2):F98-F104. Epub 2008 Jul 17. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 140 | ||||
Completion Date | October 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 36 Weeks to 42 Weeks | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Spain | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00569608 | ||||
Responsible Party | JOSE LUIS CASTELL RIPOLL, FUNDACION INVESTIGACION HOSPITAL LA FE | ||||
Secondary IDs †† | AP015/06 | ||||
Study Sponsor † | Fundacion Para La Investigacion Hospital La Fe | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Fundacion Para La Investigacion Hospital La Fe | ||||
Verification Date | June 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |