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OpenTrials
Completed

NCT Number: NCT00569608

Early Hospital Discharge Program in Neonatology

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.

Completed

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Key information

Age range

36 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Fe

Valencia, 46009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prematurity
  • No need for hospital support
  • Parents fulfill sociological score
  • Cooperation of primary care pediatrician

Exclusion criteria

  • Active disease
  • Need for hospital intervention
  • Major congenital malformations
  • Chromosomopathies

Treatment and study plan

Early Discharge

Other

Application of an early discharge protocol from the neonatal intensive care unit.

Primary outcomes

  1. Reduction in the length of hospitalization.

    Time frame: Days of hospitalization

Secondary outcomes

  1. Parental stress

    Time frame: up to 3 months post discharge

  2. Use of Health Resources of the Community

    Time frame: up to 3 months post discharge

  3. Reduction in cost of hospitalization

    Time frame: Reduction in euros/baby

Sponsors and collaborators

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe

Other

Registry information

Official study title

Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit

Acronym: EDNEO

Important dates

Study start
2005
Study completion
2006
First posted
Dec 7, 2007
Registry last updated
Dec 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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