Cholestasis in NewbornNCT02692326
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
A study testing Cyclic parenteral nutrition in people with Cholestasis in Newborn, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at… Read more about this study
- Who is it for?
- Ages 10 to 50 days
- Conditions the study is for
- Cholestasis in Newborn
- What is being tested?
- Cyclic parenteral nutrition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2010to Mar 2015
- 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 10 to 50 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns who needed long-term PN for more than ten days and were diagnosed with a pathology that makes likely the need to extend it.
Who cannot join
- Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at two years of chronological age and predisposing factors to the development of parenteral nutrition associated cholestasis (PNAC) between the two groups, and to evaluate the adverse effects of the method of cycling used.
This was a single-center, prospective randomized not blinded study was conducted in a level 3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians were excluded.
- Conditions
- Cholestasis in Newborn
- Being tested
- Cyclic parenteral nutrition
- Keywords
- intrahepatic cholestasis, infant newborn, cyclic parenteral nutrition
- Medical subject headings
- Cholestasis, Intrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclic parenteral nutritionProcedure or surgery
Cyclic parenteral nutrition was provided according to a method described by Longhurst et al. Patients were initially cycled of PN for 1 hour per day with increased rate of 1 hour with a maximum time out of PN of 4 hours for preterm babies < 37 weeks GA and 6 hours for term newborns. Glucose was monitored at half the time without PN to detect the hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Cyclic parenteral nutrition Cohort | Experimental | All newborn who were included in the study to receive cyclic parenteral nutrition (within 24 hours). The parenteral nutrition was stopped for one hour the first day until 4 hours in preterm infants and 6 hours in term neonates. Receives: Procedure: Cyclic parenteral nutrition |
| Control: Continuous parenteral nutrition | No intervention | All newborn who were included in the study to receive continuous parenteral nutrition (24 hours). The parenteral nutrition was given by a central line in 24 hours with a basal flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
% patients with parenteral nutrition associated cholestasis (PNAC)
The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
Incidence of sepsis
The percentage of patients who was diagnosed of sepsis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Incidence of catheter related sepsis (CRS)
The percentage of patients who was diagnosed of CRS in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Mean length of hospital stay
The mean length of hospital stay in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Nutrition factors to the development of PNAC
total days on enteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Nutrition factors to the development of PNAC
total days on parenteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Anticholestatic drugs
% of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Anticholestatic drugs
days of duration of treatment with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Measured: through study completion, an average of 1 year
Adverse effects of the method of cycling used
Percentage of adverse effects, type of adverse affects
Measured: through study completion, an average of 1 year
Mortality
the percentage of patients who died and the cause of death
Measured: through study completion, an average of 1 year
Mortality
The cause of death
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startAug 2010
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholestasis in NewbornStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692326
- Sponsor's protocol ID
- 2014-12
- Status last verified
- Feb 2016
- First submitted
- 16 Dec 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Angelico M, Della Guardia P. Review article: hepatobiliary complications associated with total parenteral nutrition. Aliment Pharmacol Ther. 2000 May;14 Suppl 2:54-7. doi: 10.1046/j.1365-2036.2000.014s2054.x.
PubMed 10903005
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
- ClinicalTrials.gov ID
- NCT02692326
- Acronym / sponsor ID
- 2014-12
- Conditions
- Cholestasis in Newborn
- Keywords
- intrahepatic cholestasis, infant newborn, cyclic parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Feb 2016 (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.
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at two years of chronological age and predisposing factors to the development of parenteral nutrition associated cholestasis (PNAC) between the two groups, and to evaluate the adverse effects of the method of cycling used.
This was a single-center, prospective randomized not blinded study was conducted in a level 3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians were excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Cyclic parenteral nutrition Cohort | Experimental | Procedure: Cyclic parenteral nutritionAll newborn who were included in the study to receive cyclic parenteral nutrition (within 24 hours). The parenteral nutrition was stopped for one hour the first day until 4 hours in preterm infants and 6 hours in term neonates. |
| Control: Continuous parenteral nutrition | No intervention | –All newborn who were included in the study to receive continuous parenteral nutrition (24 hours). The parenteral nutrition was given by a central line in 24 hours with a basal flow |
Who may qualify
- Ages
- 10 to 50 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns who needed long-term PN for more than ten days and were diagnosed with a pathology that makes likely the need to extend it.
Key exclusion criteria (1 listed)
- Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians
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 |
|---|---|---|
| Cyclic parenteral nutritionCyclic parenteral nutrition was provided according to a method described by Longhurst et al. Patients were initially cycled of PN for 1 hour per day with increased rate of 1 hour with a maximum time out of PN of 4 hours for preterm babies < 37 weeks GA and 6 hours for term newborns. Glucose was monitored at half the time without PN to detect the hypoglycemia. | Procedure or surgery | Intervention: Cyclic parenteral nutrition Cohort |
Primary outcome
% patients with parenteral nutrition associated cholestasis (PNAC)
Time frame: through study completion, an average of 1 year
The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
10 secondary outcomes
Incidence of sepsis
Time frame: through study completion, an average of 1 year
Incidence of catheter related sepsis (CRS)
Time frame: through study completion, an average of 1 year
Mean length of hospital stay
Time frame: through study completion, an average of 1 year
Nutrition factors to the development of PNAC
Time frame: through study completion, an average of 1 year
Nutrition factors to the development of PNAC
Time frame: through study completion, an average of 1 year
Anticholestatic drugs
Time frame: through study completion, an average of 1 year
Anticholestatic drugs
Time frame: through study completion, an average of 1 year
Adverse effects of the method of cycling used
Time frame: through study completion, an average of 1 year
Mortality
Time frame: through study completion, an average of 1 year
Mortality
Time frame: through study completion, an average of 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 26 Feb 2016.
- Background: PubMed 10903005Angelico M, Della Guardia P. Review article: hepatobiliary complications associated with total parenteral nutrition. Aliment Pharmacol Ther. 2000 May;14 Suppl 2:54-7. doi: 10.1046/j.1365-2036.2000.014s2054.x.
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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.
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?
A study testing Cyclic parenteral nutrition in people with Cholestasis in Newborn, run by Hospital General Universitario Gregorio Marañon 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 1 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 26 Feb 2016. 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?
% patients with parenteral nutrition associated cholestasis (PNAC) (time frame: through study completion, an average of 1 year). 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 NCT02692326, which also lists 1 linked publication.
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 26 Feb 2016.