Very Low Birth WeightNeoNecNCT01817062
Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen
An observational study of Very Low Birth Weight, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Objective: Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of… Read more about this study
- Who is it for?
- Ages 1 minute to 4 weeks
- Conditions the study is for
- Very Low Birth Weight
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Mar 2013
- Phase
- Observational
- 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 1 minute to 4 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with very low birth weight and surgery therapy of acute abdomen
Who may be able to join
- All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on "Campus Charité Mitte" or "Charité Virchow - Klinikum".
- Neonates (calculated date of birth + 4 weeks)
Who cannot join
- Birth weight > 1500g
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - University Berlin
Berlin, State of Berlin, 13353
About this study
Official title: Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.
Objective:
Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy.
Question:
Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?
- Conditions
- Very Low Birth Weight
- Keywords
- Capillary leakage, Acute Abdomen, Low birth weight
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Neonates with very low birth weight and surgery therapy of acute abdomen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Capillary Leakage
Postoperative Capillary Leakage (defined as weight gain within 48 hours or development of oedema within 48 hours)
Measured: 48 hours from Baseline (Operation)
Secondary outcomes (4)
Amount of transfusions during surgery
Measured: Up to 5 hours
Re-surgery rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Length of stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Mortality
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2001
- Primary completionDec 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth WeightStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817062
- Sponsor's protocol ID
- NeoNec
- Acronym
- NeoNec
- Status last verified
- May 2013
- First submitted
- 20 Mar 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.
- ClinicalTrials.gov ID
- NCT01817062
- Acronym / sponsor ID
- NeoNec / NeoNec
- Conditions
- Very Low Birth Weight
- Keywords
- Capillary leakage, Acute Abdomen, Low birth weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Mar 2013 (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.
Objective:
Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy.
Question:
Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | –Neonates with very low birth weight and surgery therapy of acute abdomen |
Who may qualify
- Ages
- 1 minute to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with very low birth weight and surgery therapy of acute abdomen
Key inclusion criteria (2 listed)
- All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on "Campus Charité Mitte" or "Charité Virchow - Klinikum".
- Neonates (calculated date of birth + 4 weeks)
Key exclusion criteria (1 listed)
- Birth weight > 1500g
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Capillary Leakage
Time frame: 48 hours from Baseline (Operation)
Postoperative Capillary Leakage (defined as weight gain within 48 hours or development of oedema within 48 hours)
4 secondary outcomes
Amount of transfusions during surgery
Time frame: Up to 5 hours
Re-surgery rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Mortality
Time frame: Up to 1 year
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 8 May 2013.
Related trials for Very Low Birth Weight
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruiting
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Prematurity; Extreme
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 1 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 8 May 2013. 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 Germany. 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?
Postoperative Capillary Leakage (time frame: 48 hours from Baseline (Operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2013.