Cholestasis in NewbornNCT06366880
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
A study testing Parenteral nutrition cycling in people with Cholestasis in Newborn, run by Hospital Pediátrico de Sinaloa at 1 site in Mexico.
Trial summary
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Cholestasis in Newborn
- What is being tested?
- Parenteral nutrition cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteMexico
- Study dates
- 11 Mar 2024to 15 Dec 2025
- 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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chylothorax
- Intestinal obstruction
- Intestinal malrotation
- Intestinal intussusception
- Gastroschisis
- Intestinal volvulus
Show all 12Show fewer
- Duodenal atresia
- Enterocolitis
- Sepsis
- Septic shock
- Prolonged fast
- Authorization of the study by parents
Who cannot join
- Presence of liver diseases or malformations that cause cholestasis.
- All patients who have received medical treatment for cholestasis are excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Pediatrico de Sinaloa
Culiacán, Sinaloa, 80200
Ana Karen Camargo Angulo, Dr., 6681890586 ext. +52, anakarencamargo96@gmail.com
About this study
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.
The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.
The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants.
Read the detailed description
Methods/design:
This study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico.
A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible.
Primary outcomes Incidence of colestasis on Day 28 of admission.
Secondary outcomes are total plasma bilirrubine profiles, the incidence of hypoglycemia, hospital-acquired infections, length of hospital/NICU stay, in-hospital all-cause mortality, weight, height and head circumference.
Discussion: This RCT will examine the effects of NPTC versus late PNT in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to both treatments.
Trial registration: 2022.HPS.DI.434 (3rd March 2024)
Keywords: Parenteral nutrition cycling, Incidence of colestasis, incidence of hypoglycaemia, hospital-acquired infections, Randomised controlled trial.
- Conditions
- Cholestasis in Newborn
- Being tested
- Parenteral nutrition cycling
- Keywords
- Parenteral nutrition cycling, Incidence of colestasis, Incidence of hypoglycemia, Hospital-acquired infections, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutrition cyclingOther
Also called Cyclic parenteral nutrition, Cycling parenteral nutrition, Cycle parenteral nutrition
This study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico.
A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible.
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition cycling | Experimental | Not described Receives: Other: Parenteral nutrition cycling |
| Continuous parenteral nutrition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cholestasis on Day 28 of admission.
Proportion of cholestasis
Measured: Day 1 to 28
Secondary outcomes (2)
are total plasma bilirrubine profiles
mg/dl
Measured: Day 1 to 28
the incidence of hypoglycaemia
mg/dl
Measured: Day 1 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start11 Mar 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pediátrico de Sinaloa
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Camargo Angulo Ana Karen, Hospital Pediátrico de Sinaloa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366880
- Sponsor's protocol ID
- 2022.HPS.DI.434
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
- ClinicalTrials.gov ID
- NCT06366880
- Acronym / sponsor ID
- 2022.HPS.DI.434
- Conditions
- Cholestasis in Newborn
- Keywords
- Parenteral nutrition cycling, Incidence of colestasis, Incidence of hypoglycemia, Hospital-acquired infections, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Pediátrico de SinaloaOther government
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- 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.
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.
The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.
The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants.
Detailed description
Methods/design:
This study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico.
A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible.
Primary outcomes Incidence of colestasis on Day 28 of admission.
Secondary outcomes are total plasma bilirrubine profiles, the incidence of hypoglycemia, hospital-acquired infections, length of hospital/NICU stay, in-hospital all-cause mortality, weight, height and head circumference.
Discussion: This RCT will examine the effects of NPTC versus late PNT in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to both treatments.
Trial registration: 2022.HPS.DI.434 (3rd March 2024)
Keywords: Parenteral nutrition cycling, Incidence of colestasis, incidence of hypoglycaemia, hospital-acquired infections, Randomised controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition cycling | Experimental | Other: Parenteral nutrition cycling |
| Continuous parenteral nutrition | No intervention | – |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Chylothorax
- Intestinal obstruction
- Intestinal malrotation
- Intestinal intussusception
- Gastroschisis
Key exclusion criteria (2 listed)
- Presence of liver diseases or malformations that cause cholestasis.
- All patients who have received medical treatment for cholestasis are excluded.
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 |
|---|---|---|
| Parenteral nutrition cyclingAlso: Cyclic parenteral nutrition, Cycling parenteral nutrition, Cycle parenteral nutritionThis study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico. A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible. | Other | Parenteral nutrition cycling |
Primary outcome
Incidence of cholestasis on Day 28 of admission.
Time frame: Day 1 to 28
Proportion of cholestasis
2 secondary outcomes
are total plasma bilirrubine profiles
Time frame: Day 1 to 28
the incidence of hypoglycaemia
Time frame: Day 1 to 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral nutrition cycling in people with Cholestasis in Newborn, run by Hospital Pediátrico de Sinaloa at 1 site in Mexico.
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 12 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Karen Camargo Angulo, Dr. (6681890586 ext. +52, anakarencamargo96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cholestasis on Day 28 of admission. (time frame: Day 1 to 28). 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 16 Apr 2024.