PrematurityEDNEONCT00569608
Early Hospital Discharge Program in Neonatology
A study testing Early Discharge in people with Prematurity, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 42 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Early Discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prematurity
- No need for hospital support
- Parents fulfill sociological score
- Cooperation of primary care pediatrician
Who cannot join
- Active disease
- Need for hospital intervention
- Major congenital malformations
- Chromosomopathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit
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.
Read the 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.
- Conditions
- Prematurity
- Being tested
- Early Discharge
- Keywords
- Parental stress, Early discharge, Anxiety, Depression, Neonatal Intensive Care Unit
- Medical subject headings
- Premature Birth, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early DischargeOther
Application of an early discharge protocol from the neonatal intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| EDA | Experimental | Neonates submitted to the protocol of early discharge. Receives: Other: Early Discharge |
| SDP | No intervention | Discharge following the standard protocol of the neonatal intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the length of hospitalization.
Measured: Days of hospitalization
Secondary outcomes (3)
Parental stress
Measured: up to 3 months post discharge
Use of Health Resources of the Community
Measured: up to 3 months post discharge
Reduction in cost of hospitalization
Measured: Reduction in euros/baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startJan 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Para La Investigacion Hospital La Fe
- Sponsor type
- University, hospital or other
- Investigators
- PILAR SAENZ, MD, Study director, AGENCIA VALENCIANA DE SALUT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569608
- Sponsor's protocol ID
- FIHLaFe
- Other IDs
- AP015/06
- Acronym
- EDNEO
- Status last verified
- Jun 2005
- First submitted
- 6 Dec 2007
- Last updated
- 7 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Psychological distress in parents of premature infants at discharge from the nicu. Saénz P1, Cerdá M1, Gorba M1, Díaz Cordobés JL2, Yi, P2, Barreto, P2 ;Vento M (Sponsored by Maximo V, Prof)1Servicio de Neonatología, Hospital Universitario Materno Infantil La Fe, Valencia, Spain and 2Departamento de Personalidad, Evaluación y Tratamientos Psicológicos., Facultad de Psicología., Valencia, Spain. EPAS 2007; 616280.26
Psychological follow up of parents of preterm infants enrolled in an early discharge program from the nicu. Saénz P1, Díaz Cordobés JL2, Cerdá M1, Boronat N1, Barreto P2, Yi P2; Vento M1. (Sponsored by Maximo Vento,)1Servicio de Neonatología, Hospital Universitario Materno Infantil La Fe, Valencia, Valencia, Spain and 2Dpto Personalidad, Evaluación y Tratamientos Psicológicos, Faculty of Psychology (University of Valencia), Valencia, Valencia, Spain. EPAS 2007; 616280.27
Vulnerability Of Parents Of Very Low Birth Weight Infants (Vlbw) During Nicu Hospitalization. Saénz P1, Díaz Cordobés JL2, Cerdá M1, Boronat N1, Yi P2, Barreto P2 ; Vento M1. (Sponsored by Maximo Vento, Prof)1 Servicio de Neonatología, Hospital Universitario Materno Infantil La Fe, Valencia, Valencia, Spain and 2Departamento de Personalidad, Evaluación y Tratamientos Psicológicos., Facultad de Psicología.Universidad de Valencia., Valencia, Valencia, Spain. EPAS 2007; 618442.13
Saenz P, Cerda M, Diaz 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. doi: 10.1136/adc.2007.135921. Epub 2008 Jul 17.
PubMed 18635681
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00569608
- Acronym / sponsor ID
- EDNEO / FIHLaFe
- Conditions
- Prematurity
- Keywords
- Parental stress, Early discharge, Anxiety, Depression, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fundacion Para La Investigacion Hospital La FeUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDA | Experimental | Other: Early DischargeNeonates submitted to the protocol of early discharge. |
| SDP | No intervention | –Discharge following the standard protocol of the neonatal intensive care unit. |
Who may qualify
- Ages
- 36 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Prematurity
- No need for hospital support
- Parents fulfill sociological score
- Cooperation of primary care pediatrician
Key exclusion criteria (4 listed)
- Active disease
- Need for hospital intervention
- Major congenital malformations
- Chromosomopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early DischargeApplication of an early discharge protocol from the neonatal intensive care unit. | Other | EDA |
Primary outcome
Reduction in the length of hospitalization.
Time frame: Days of hospitalization
3 secondary outcomes
Parental stress
Time frame: up to 3 months post discharge
Use of Health Resources of the Community
Time frame: up to 3 months post discharge
Reduction in cost of hospitalization
Time frame: Reduction in euros/baby
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2007.
- Results publicationPsychological distress in parents of premature infants at discharge from the nicu. Saénz P1, Cerdá M1, Gorba M1, Díaz Cordobés JL2, Yi, P2, Barreto, P2 ;Vento M (Sponsored by Maximo V, Prof)1Servicio de Neonatología, Hospital Universitario Materno Infantil La Fe, Valencia, Spain and 2Departamento de Personalidad, Evaluación y Tratamientos Psicológicos., Facultad de Psicología., Valencia, Spain. EPAS 2007; 616280.26
- Results publicationPsychological follow up of parents of preterm infants enrolled in an early discharge program from the nicu. Saénz P1, Díaz Cordobés JL2, Cerdá M1, Boronat N1, Barreto P2, Yi P2; Vento M1. (Sponsored by Maximo Vento,)1Servicio de Neonatología, Hospital Universitario Materno Infantil La Fe, Valencia, Valencia, Spain and 2Dpto Personalidad, Evaluación y Tratamientos Psicológicos, Faculty of Psychology (University of Valencia), Valencia, Valencia, Spain. EPAS 2007; 616280.27
- Results publicationVulnerability Of Parents Of Very Low Birth Weight Infants (Vlbw) During Nicu Hospitalization. Saénz P1, Díaz Cordobés JL2, Cerdá M1, Boronat N1, Yi P2, Barreto P2 ; Vento M1. (Sponsored by Maximo Vento, Prof)1 Servicio de Neonatología, Hospital Universitario Materno Infantil La Fe, Valencia, Valencia, Spain and 2Departamento de Personalidad, Evaluación y Tratamientos Psicológicos., Facultad de Psicología.Universidad de Valencia., Valencia, Valencia, Spain. EPAS 2007; 618442.13
- Derived from this study: PubMed 18635681Saenz P, Cerda M, Diaz 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. doi: 10.1136/adc.2007.135921. Epub 2008 Jul 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PILAR SAENZ, MD study director
AGENCIA VALENCIANA DE SALUT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Discharge in people with Prematurity, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the length of hospitalization. (time frame: Days of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00569608, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2007.