Growth FailureNCT03730883

The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants

A study testing Central line removal at 100ml/kg/day. and Central line removal at 140ml/kg/day. in people with Growth Failure and CLABSI - Central Line Associated Bloodstream Infection, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 4 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants. Half of participants will have a central line removed at ≥100 ml/kg/d, while the other half will have a central line removed at ≥ 140 ml/kg/day. Read more about this study

Who is it for?: Ages Up to 2 weeks
Conditions the study is for: Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
What is being tested?: Central line removal at 100ml/kg/day. and Central line removal at 140ml/kg/day.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 4 sitesPoland
Study dates: 26 Jan 2019to 1 Feb 2024
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 Up to 2 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Birth weight ≤ 1500 g (very low birth weight).
Birth weight ≥ 3rd percentile at a given gestational age.
Central line inserted (PICC or UVC).
Oral intake not exceeding 100 ml/kg/d at randomization.
Lack of congenital illness or malformation that may affect growth.
Signed parental consent.

Who cannot join

Birth weight > 1500 g.
Birth weight < 3rd percentile at a given gestational age.
The absence of a central line.
Oral intake ≥100 ml/kg/d at randomization.
Congenital illness or malformation that may affect growth.
Lack of informed consent.
Participation in other intervention (investigational) trials, that may affect the primary outcome.

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
Department of Reproductive Health, Centre of Postgraduate Medical Education
Warsaw, 01-004
Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw
Warsaw, 02-015
Department of Neonatology, Wroclaw Medical University
Wroclaw, 50-556

Other trials in Poland

About this study

Official title: The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants: A Non-inferiority, Randomized Controlled Trial

Read the detailed description

Eligible infants will be randomized in equal proportions between two groups. In the first group (group A - early central line removal) central line will be removed at the time the infant reaches 100 ml/kg/d of enteral intake. In the second group (group B - standard central line removal) central line will be removed at the time the infant reaches 140 ml/kg/d of enteral intake (full enteral intake). Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present:

necessity of administration of drugs that must be given via central venous access,
necessity of administration of drugs that must be given intravenously along with difficulties to secure peripheral venous access,
necessity of prolonged (> 7 days) administration of drugs that must be given intravenously,
necessity to continue parenteral nutrition along with difficulties to secure peripheral venous access.

Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in group A will continue to receive parenteral nutrition via peripheral venous access at the discretion of the physician taking care for the infant. The solution used to continue parenteral nutrition via peripheral venous access will contain at maximum 2,5% amino acids, 10% glucose and no calcium or phosphate preparations to ensure fluid's osmolality will not exceed 900 mOsm/l and the solution will be well tolerated when administered via peripheral vein.

Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.

Conditions: Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
Being tested: Central line removal at 100ml/kg/day., Central line removal at 140ml/kg/day.
Medical subject headings: Failure to Thrive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Central line removal at 100ml/kg/day.Procedure or surgery
In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake if well tolerated.
Central line removal at 140ml/kg/day.Procedure or surgery
In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.

Study groups in NCT03730883
Study group	Role	What they receive
Central line removal at 100ml/kg/day.	Experimental	In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake. Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present. Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in this group may continue to receive parenteral nutrition via peripheral venous access, depending on the decision of the physician taking care for the infant. Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist. Receives: Procedure: Central line removal at 100ml/kg/day.
Central line removal at 140 ml/kg/day.	Active comparator	In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake (full enteral intake). In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake. Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present. Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist. Receives: Procedure: Central line removal at 140ml/kg/day.

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight at 36 weeks PMA.
Difference between the two intervention arms in weight at 36 weeks PMA. Noninferiority would be declared if a mean difference in weight at 36 weeks PMA will be no more than 210 g.
Measured: 36 weeks PMA.

Secondary outcomes (10)

Head circumference at 36 weeks PMA.
Difference between the two intervention arms in head circumference at 36 weeks PMA.
Measured: 36 weeks PMA.
Length at 36 weeks PMA.
Difference between the two intervention arms in length at 36 weeks PMA.
Measured: 36 weeks PMA.
The rate of CLABSI.
The rate of CLA-BSI in both groups.
Measured: From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.
Time to regain birth weight.
If the infants remain above their birth weight for 3 consecutive days, the first day of the 3 weights will be used as the date of regaining birth weight.
Measured: Up to 4 weeks.
Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.
Safety of early central line removal will be assessed in respect to number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.
Measured: Up to 7 days post-intervention.
Central line insertion due to feeding intolerance.
Need for central line insertion within 7 days following intervention because of feeding intolerance.
Measured: Up tp 7 days post-intervention.
Weight at 18 to 22 months corrected age (CA).
Weight at the age of 18 to 22 months corrected age (CA) will be assessed for noninferiority.
Measured: At 18 to 22 months corrected age (CA).
Length at 18 to 22 months corrected age (CA).
Length at the age of 18 to 22 months corrected age (CA) will be assessed for noninferiority.
Measured: At 18 to 22 months corrected age (CA)
Head circumference at 18 to 22 months corrected age (CA).
Head circumference at the age of 18 to 22 months corrected age (CA) will be assessed for noninferiority.
Measured: At 18 to 22 months corrected age (CA).
Length of hospital stay.
The data on the length of hospital stay expressed in days will be recorded.
Measured: Through study completion, an average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 20191 Feb 2024

First posted5 Nov 2018
Study start26 Jan 2019
Primary completion10 Apr 2022
Study completion1 Feb 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Growth FailureStudies 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: None (open label)
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03730883
Sponsor's protocol ID: CLAG'18
Status last verified: Jan 2022
First submitted: 1 Nov 2018
Last updated: 6 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial will be available, after deidentiﬁcation. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

Publications

Poindexter B. Approaches to growth faltering. World Rev Nutr Diet. 2014;110:228-38. doi: 10.1159/000358471. Epub 2014 Apr 11.
PubMed 24751633
Sengupta A, Lehmann C, Diener-West M, Perl TM, Milstone AM. Catheter duration and risk of CLA-BSI in neonates with PICCs. Pediatrics. 2010 Apr;125(4):648-53. doi: 10.1542/peds.2009-2559. Epub 2010 Mar 15.
PubMed 20231192
Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211.
PubMed 19403500
Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. doi: 10.1016/s0146-0005(03)00044-2.
PubMed 14510321
Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.
PubMed 16585322
Ibrahim HM, Jeroudi MA, Baier RJ, Dhanireddy R, Krouskop RW. Aggressive early total parental nutrition in low-birth-weight infants. J Perinatol. 2004 Aug;24(8):482-6. doi: 10.1038/sj.jp.7211114.
PubMed 15167885
Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.
PubMed 15547163
Alshaikh B, Yee W, Lodha A, Henderson E, Yusuf K, Sauve R. Coagulase-negative staphylococcus sepsis in preterm infants and long-term neurodevelopmental outcome. J Perinatol. 2014 Feb;34(2):125-9. doi: 10.1038/jp.2013.155. Epub 2013 Dec 19.
PubMed 24355942
Donovan EF, Sparling K, Lake MR, Narendran V, Schibler K, Haberman B, Rose B, Meinzen-Derr J; Ohio Perinatal Quality Collaborative. The investment case for preventing NICU-associated infections. Am J Perinatol. 2013 Mar;30(3):179-84. doi: 10.1055/s-0032-1322516. Epub 2012 Jul 26.
PubMed 22836823
O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081
Milstone AM, Reich NG, Advani S, Yuan G, Bryant K, Coffin SE, Huskins WC, Livingston R, Saiman L, Smith PB, Song X. Catheter dwell time and CLABSIs in neonates with PICCs: a multicenter cohort study. Pediatrics. 2013 Dec;132(6):e1609-15. doi: 10.1542/peds.2013-1645. Epub 2013 Nov 11.
PubMed 24218474
Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18.
PubMed 24249819
Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282.
PubMed 18829797
Romanska J, Margas W, Bokiniec R, Krajewski P, Seliga-Siwecka J. Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial. BMJ Open. 2019 Sep 17;9(9):e030167. doi: 10.1136/bmjopen-2019-030167.
PubMed 31530607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Growth Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants: A Non-inferiority, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03730883
Acronym / sponsor ID: CLAG'18
Conditions: Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 214 participants (actual)
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
Collaborators: Nutricia Foundation
Study start: 26 Jan 2019 (actual)
Primary completion: 10 Apr 2022 (actual)
Study completion: 1 Feb 2024 (estimated)
First posted: 5 Nov 2018 (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.

Detailed description

necessity of administration of drugs that must be given via central venous access,
necessity of administration of drugs that must be given intravenously along with difficulties to secure peripheral venous access,
necessity of prolonged (> 7 days) administration of drugs that must be given intravenously,
necessity to continue parenteral nutrition along with difficulties to secure peripheral venous access.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Central line removal at 100ml/kg/day.	Experimental	Procedure: Central line removal at 100ml/kg/day.In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake. Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present. Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in this group may continue to receive parenteral nutrition via peripheral venous access, depending on the decision of the physician taking care for the infant. Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.
Central line removal at 140 ml/kg/day.	Active comparator	Procedure: Central line removal at 140ml/kg/day.In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake (full enteral intake). In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake. Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present. Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.

Who may qualify

Ages: Up to 2 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Birth weight ≤ 1500 g (very low birth weight).
Birth weight ≥ 3rd percentile at a given gestational age.
Central line inserted (PICC or UVC).
Oral intake not exceeding 100 ml/kg/d at randomization.
Lack of congenital illness or malformation that may affect growth.

Key exclusion criteria (7 listed)

Birth weight > 1500 g.
Birth weight < 3rd percentile at a given gestational age.
The absence of a central line.
Oral intake ≥100 ml/kg/d at randomization.
Congenital illness or malformation that may affect growth.

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
Central line removal at 100ml/kg/day.In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake if well tolerated.	Procedure or surgery	Central line removal at 100ml/kg/day.
Central line removal at 140ml/kg/day.In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.	Procedure or surgery	Central line removal at 140 ml/kg/day.

Primary outcome

Weight at 36 weeks PMA.
Time frame: 36 weeks PMA.
Difference between the two intervention arms in weight at 36 weeks PMA. Noninferiority would be declared if a mean difference in weight at 36 weeks PMA will be no more than 210 g.

10 secondary outcomes

Head circumference at 36 weeks PMA.
Time frame: 36 weeks PMA.
Length at 36 weeks PMA.
Time frame: 36 weeks PMA.
The rate of CLABSI.
Time frame: From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.
Time to regain birth weight.
Time frame: Up to 4 weeks.
Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.
Time frame: Up to 7 days post-intervention.
Central line insertion due to feeding intolerance.
Time frame: Up tp 7 days post-intervention.
Weight at 18 to 22 months corrected age (CA).
Time frame: At 18 to 22 months corrected age (CA).
Length at 18 to 22 months corrected age (CA).
Time frame: At 18 to 22 months corrected age (CA)
Head circumference at 18 to 22 months corrected age (CA).
Time frame: At 18 to 22 months corrected age (CA).
Length of hospital stay.
Time frame: Through study completion, an average of 2 years.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Background: PubMed 24751633Poindexter B. Approaches to growth faltering. World Rev Nutr Diet. 2014;110:228-38. doi: 10.1159/000358471. Epub 2014 Apr 11.
Background: PubMed 20231192Sengupta A, Lehmann C, Diener-West M, Perl TM, Milstone AM. Catheter duration and risk of CLA-BSI in neonates with PICCs. Pediatrics. 2010 Apr;125(4):648-53. doi: 10.1542/peds.2009-2559. Epub 2010 Mar 15.
Background: PubMed 19403500Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211.
Background: PubMed 14510321Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. doi: 10.1016/s0146-0005(03)00044-2.
Background: PubMed 16585322Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.
Background: PubMed 15167885Ibrahim HM, Jeroudi MA, Baier RJ, Dhanireddy R, Krouskop RW. Aggressive early total parental nutrition in low-birth-weight infants. J Perinatol. 2004 Aug;24(8):482-6. doi: 10.1038/sj.jp.7211114.
Background: PubMed 15547163Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.
Background: PubMed 24355942Alshaikh B, Yee W, Lodha A, Henderson E, Yusuf K, Sauve R. Coagulase-negative staphylococcus sepsis in preterm infants and long-term neurodevelopmental outcome. J Perinatol. 2014 Feb;34(2):125-9. doi: 10.1038/jp.2013.155. Epub 2013 Dec 19.
Background: PubMed 22836823Donovan EF, Sparling K, Lake MR, Narendran V, Schibler K, Haberman B, Rose B, Meinzen-Derr J; Ohio Perinatal Quality Collaborative. The investment case for preventing NICU-associated infections. Am J Perinatol. 2013 Mar;30(3):179-84. doi: 10.1055/s-0032-1322516. Epub 2012 Jul 26.
Background: PubMed 21511081O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
Background: PubMed 24218474Milstone AM, Reich NG, Advani S, Yuan G, Bryant K, Coffin SE, Huskins WC, Livingston R, Saiman L, Smith PB, Song X. Catheter dwell time and CLABSIs in neonates with PICCs: a multicenter cohort study. Pediatrics. 2013 Dec;132(6):e1609-15. doi: 10.1542/peds.2013-1645. Epub 2013 Nov 11.
Background: PubMed 24249819Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18.
IHI - How-to Guide: Prevent Central Line-Associated Bloodstream Infections. Cambridge, MA: Institute for Healthcare Improvement; 2012Link provided by the sponsor.
International Fetal and Newborn Growth Standards for the 21st Century. Anthropometry Handbook. University of Oxford; 2012Link provided by the sponsor.
Nutritional Support of the Very Low Birth Weight Infant. Toolkit Rev.2018.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available, after deidentiﬁcation. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

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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.

Justyna Romanska, MD principal investigator

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. 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?

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?

Weight at 36 weeks PMA. (time frame: 36 weeks PMA.). 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 NCT03730883, which also lists 14 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 6 Jul 2022.