Infant, Newborn, DiseasesNCT05945017

Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

A study testing Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748 in people with Infant, Newborn, Diseases and Infant Development, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages Up to 32 weeks
Conditions the study is for: Infant, Newborn, Diseases, Infant Development
What is being tested?: Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 1 siteSpain
Study dates: 1 Jan 2014to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 32 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Premature infants under 32 weeks gestational age and less than 1500g birthweight.
Born at BCNatal Hospital Clínic between years 2014-2019.

Who cannot join

All neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded.
Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)

Trial locations and contacts

1 site in 1 country.

Spain1 site

Neonataology Service, BCNatal Hospital Clinic Seu Maternitat
Barcelona, 08028

Other trials in Spain

About this study

Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers.

Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.

Conditions: Infant, Newborn, Diseases, Infant Development
Being tested: Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Keywords: Probiotics, Bifidobacterium bifidum, Lactobacillus acidophilus, Neurodevelopment, Prematurity, Late-onset sepsis
Medical subject headings: Infant, Newborn, Diseases, Premature Birth

What participants receive

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

Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748Dietary supplement

Study groups in NCT05945017
Study group	Role	What they receive
Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748	Experimental	Daily dose of 6x109 UFC Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) from 7 days of life until reaching a postmenstrual age of 34 weeks or discharge Receives: Dietary Supplement: Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Control	No intervention	Untreated control group

What is being measured

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

Degree of neurodevelopment at 24 months corrected age
Normal neurodevelopment will be considered when no muscle tone changes, no impaired fine or gross motor coordination, Bayley scale score between above 84, no behaviour disorders or visual disability.
Measured: 24 months
Degree of neurodevelopment at 24 months corrected age
Mild impairment will be considered if any of the following: muscle tone changes, impaired fine or gross motor coordination, Bayley scale score between 71-84, moderate behaviour disorders or mild visual disability.
Measured: 24 months
Degree of neurodevelopment at 24 months corrected age
Moderate impairment will be diagnosed when suffering from any of the following: spastic diplegia, hemiplegia, seizures (non-febrile), Bayley scores between 50-70, severe behaviour disorders, moderate visual disability or mild-moderate hypoacusis.
Measured: 24 months
Degree of neurodevelopment at 24 months corrected age
Severe impairment will be attributed to subjects with any of the following: spastic quadriplegia, choreoathetosis, ataxia, Bayley score <50, blindness or severe hypoacusis
Measured: 24 months
Degree of neurodevelopment at 6 years of age
Wechsler Intelligence Scale for Children - Fifth edition. Ranges from below 69 to above 130. Scores from 90-109 indicate average, above it indicates above average and below, below average performance.
Measured: 6 years
Degree of neurodevelopment at 6 years of age
Child behaviour checklist 6-18 years of age. 113 items about behaviour and social competence scored from 0 "absent" to 2 "occurs often"
Measured: 6 years
Degree of neurodevelopment at 6 years of age
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2). Parent/teacher self reporting form.
Measured: 6 years
Neuroplasticity biomarkers and intestinal permeability
NeuN, Doublecortin, GFAP, GDNF, Ki67, Nrf2, BDNF, NGF, neurotrophin-1 (NT-1), neurotrophin-3 (NT-3), neurotrophin-4 (NT-4), DYRK1A, HIF1α, S100B i GSK3B. IL1B, IL6, IL8, IL10, IL12, TNF- α
Measured: 6 years

Secondary outcomes (5)

Incidence of necrotising enterocolitis
cases fulfilling the stage II or above of the modified Bell's Criteria
Measured: 40 weeks
Mortality
Proportion of dead participants before discharge
Measured: 40 weeks
Incidence of late onset sepsis
positive blood culture beyond 72 hours of life
Measured: 40 weeks
Incidence of Intraventricular haemorrhage
Grade I-IV
Measured: 40 weeks
Intensive care length of stay
Days of intensive care
Measured: 40 weeks

Timeline

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

1 Jan 201431 Dec 2027

First posted14 Jul 2023
Study start1 Jan 2014
Primary completion31 Dec 2019
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Infant, Newborn, DiseasesStudies 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: Non-randomised
Intervention model: Sequential
Model description: Sequential study with consecutive recruitment with a washout period of 12 months between groups
Masking: None (open label)
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05945017
Sponsor's protocol ID: HCB/2021/0454
Status last verified: Aug 2023
First submitted: 19 May 2023
Last updated: 14 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sjogren YM, Jenmalm MC, Bottcher MF, Bjorksten B, Sverremark-Ekstrom E. Altered early infant gut microbiota in children developing allergy up to 5 years of age. Clin Exp Allergy. 2009 Apr;39(4):518-26. doi: 10.1111/j.1365-2222.2008.03156.x. Epub 2009 Feb 9.
PubMed 19220322
O'Reilly H, Johnson S, Ni Y, Wolke D, Marlow N. Neuropsychological Outcomes at 19 Years of Age Following Extremely Preterm Birth. Pediatrics. 2020 Feb;145(2):e20192087. doi: 10.1542/peds.2019-2087. Epub 2020 Jan 10.
PubMed 31924688
Food and Agricultural Organization of the United Nations and World Health Organization. Health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria. World Health Organization, (2001).
Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
PubMed 32727119
Mai V, Young CM, Ukhanova M, Wang X, Sun Y, Casella G, Theriaque D, Li N, Sharma R, Hudak M, Neu J. Fecal microbiota in premature infants prior to necrotizing enterocolitis. PLoS One. 2011;6(6):e20647. doi: 10.1371/journal.pone.0020647. Epub 2011 Jun 6.
PubMed 21674011
Underwood MA, Sohn K. The Microbiota of the Extremely Preterm Infant. Clin Perinatol. 2017 Jun;44(2):407-427. doi: 10.1016/j.clp.2017.01.005. Epub 2017 Mar 22.
PubMed 28477669
Thomas JP, Raine T, Reddy S, Belteki G. Probiotics for the prevention of necrotising enterocolitis in very low-birth-weight infants: a meta-analysis and systematic review. Acta Paediatr. 2017 Nov;106(11):1729-1741. doi: 10.1111/apa.13902. Epub 2017 Jun 9.
PubMed 28471478
Baucells BJ, Mercadal Hally M, Alvarez Sanchez AT, Figueras Aloy J. [Probiotic associations in the prevention of necrotising enterocolitis and the reduction of late-onset sepsis and neonatal mortality in preterm infants under 1,500g: A systematic review]. An Pediatr (Barc). 2016 Nov;85(5):247-255. doi: 10.1016/j.anpedi.2015.07.038. Epub 2015 Nov 21. Spanish.
PubMed 26611880
Bi LW, Yan BL, Yang QY, Li MM, Cui HL. Which is the best probiotic treatment strategy to prevent the necrotizing enterocolitis in premature infants: A network meta-analysis revealing the efficacy and safety. Medicine (Baltimore). 2019 Oct;98(41):e17521. doi: 10.1097/MD.0000000000017521.
PubMed 31593123
van den Akker CHP, van Goudoever JB, Shamir R, Domellof M, Embleton ND, Hojsak I, Lapillonne A, Mihatsch WA, Berni Canani R, Bronsky J, Campoy C, Fewtrell MS, Fidler Mis N, Guarino A, Hulst JM, Indrio F, Kolacek S, Orel R, Vandenplas Y, Weizman Z, Szajewska H. Probiotics and Preterm Infants: A Position Paper by the European Society for Paediatric Gastroenterology Hepatology and Nutrition Committee on Nutrition and the European Society for Paediatric Gastroenterology Hepatology and Nutrition Working Group for Probiotics and Prebiotics. J Pediatr Gastroenterol Nutr. 2020 May;70(5):664-680. doi: 10.1097/MPG.0000000000002655.
PubMed 32332478
Alfaleh K, Anabrees J, Bassler D, Al-Kharfi T. Probiotics for prevention of necrotizing enterocolitis in preterm infants. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD005496. doi: 10.1002/14651858.CD005496.pub3.
PubMed 21412889
Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med. 2000 Aug 10;343(6):378-84. doi: 10.1056/NEJM200008103430601.
PubMed 10933736
Hortensius LM, van Elburg RM, Nijboer CH, Benders MJNL, de Theije CGM. Postnatal Nutrition to Improve Brain Development in the Preterm Infant: A Systematic Review From Bench to Bedside. Front Physiol. 2019 Jul 26;10:961. doi: 10.3389/fphys.2019.00961. eCollection 2019.
PubMed 31404162
Cryan JF, O'Mahony SM. The microbiome-gut-brain axis: from bowel to behavior. Neurogastroenterol Motil. 2011 Mar;23(3):187-92. doi: 10.1111/j.1365-2982.2010.01664.x.
PubMed 21303428
Yang I, Corwin EJ, Brennan PA, Jordan S, Murphy JR, Dunlop A. The Infant Microbiome: Implications for Infant Health and Neurocognitive Development. Nurs Res. 2016 Jan-Feb;65(1):76-88. doi: 10.1097/NNR.0000000000000133.
PubMed 26657483

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?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
ClinicalTrials.gov ID: NCT05945017
Acronym / sponsor ID: HCB/2021/0454
Conditions: Infant, Newborn, Diseases, Infant Development
Keywords: Probiotics, Bifidobacterium bifidum, Lactobacillus acidophilus, Neurodevelopment, Prematurity, Late-onset sepsis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 233 participants (actual)
Lead sponsor: Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
Collaborators: Hospital Clinic of Barcelona
Study start: 1 Jan 2014 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2027 (estimated)
First posted: 14 Jul 2023 (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.

Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Sequential study with consecutive recruitment with a washout period of 12 months between groups

Arm	Type	Receives
Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748	Experimental	Dietary Supplement: Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748Daily dose of 6x109 UFC Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) from 7 days of life until reaching a postmenstrual age of 34 weeks or discharge
Control	No intervention	–Untreated control group

Who may qualify

Ages: Up to 32 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Premature infants under 32 weeks gestational age and less than 1500g birthweight.
Born at BCNatal Hospital Clínic between years 2014-2019.

Key exclusion criteria (2 listed)

All neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded.
Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)

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
Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748	Dietary supplement	Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748

Primary outcome

Degree of neurodevelopment at 24 months corrected age
Time frame: 24 months
Normal neurodevelopment will be considered when no muscle tone changes, no impaired fine or gross motor coordination, Bayley scale score between above 84, no behaviour disorders or visual disability.
Degree of neurodevelopment at 24 months corrected age
Time frame: 24 months
Mild impairment will be considered if any of the following: muscle tone changes, impaired fine or gross motor coordination, Bayley scale score between 71-84, moderate behaviour disorders or mild visual disability.
Degree of neurodevelopment at 24 months corrected age
Time frame: 24 months
Moderate impairment will be diagnosed when suffering from any of the following: spastic diplegia, hemiplegia, seizures (non-febrile), Bayley scores between 50-70, severe behaviour disorders, moderate visual disability or mild-moderate hypoacusis.
Degree of neurodevelopment at 24 months corrected age
Time frame: 24 months
Severe impairment will be attributed to subjects with any of the following: spastic quadriplegia, choreoathetosis, ataxia, Bayley score <50, blindness or severe hypoacusis
Degree of neurodevelopment at 6 years of age
Time frame: 6 years
Wechsler Intelligence Scale for Children - Fifth edition. Ranges from below 69 to above 130. Scores from 90-109 indicate average, above it indicates above average and below, below average performance.
Degree of neurodevelopment at 6 years of age
Time frame: 6 years
Child behaviour checklist 6-18 years of age. 113 items about behaviour and social competence scored from 0 "absent" to 2 "occurs often"
Degree of neurodevelopment at 6 years of age
Time frame: 6 years
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2). Parent/teacher self reporting form.
Neuroplasticity biomarkers and intestinal permeability
Time frame: 6 years
NeuN, Doublecortin, GFAP, GDNF, Ki67, Nrf2, BDNF, NGF, neurotrophin-1 (NT-1), neurotrophin-3 (NT-3), neurotrophin-4 (NT-4), DYRK1A, HIF1α, S100B i GSK3B. IL1B, IL6, IL8, IL10, IL12, TNF- α

5 secondary outcomes

Incidence of necrotising enterocolitis
Time frame: 40 weeks
Mortality
Time frame: 40 weeks
Incidence of late onset sepsis
Time frame: 40 weeks
Incidence of Intraventricular haemorrhage
Time frame: 40 weeks
Intensive care length of stay
Time frame: 40 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Background: PubMed 19220322Sjogren YM, Jenmalm MC, Bottcher MF, Bjorksten B, Sverremark-Ekstrom E. Altered early infant gut microbiota in children developing allergy up to 5 years of age. Clin Exp Allergy. 2009 Apr;39(4):518-26. doi: 10.1111/j.1365-2222.2008.03156.x. Epub 2009 Feb 9.
Background: PubMed 31924688O'Reilly H, Johnson S, Ni Y, Wolke D, Marlow N. Neuropsychological Outcomes at 19 Years of Age Following Extremely Preterm Birth. Pediatrics. 2020 Feb;145(2):e20192087. doi: 10.1542/peds.2019-2087. Epub 2020 Jan 10.
Results publicationFood and Agricultural Organization of the United Nations and World Health Organization. Health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria. World Health Organization, (2001).
Results publication: PubMed 32727119Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
Results publication: PubMed 21674011Mai V, Young CM, Ukhanova M, Wang X, Sun Y, Casella G, Theriaque D, Li N, Sharma R, Hudak M, Neu J. Fecal microbiota in premature infants prior to necrotizing enterocolitis. PLoS One. 2011;6(6):e20647. doi: 10.1371/journal.pone.0020647. Epub 2011 Jun 6.
Results publication: PubMed 28477669Underwood MA, Sohn K. The Microbiota of the Extremely Preterm Infant. Clin Perinatol. 2017 Jun;44(2):407-427. doi: 10.1016/j.clp.2017.01.005. Epub 2017 Mar 22.
Results publication: PubMed 28471478Thomas JP, Raine T, Reddy S, Belteki G. Probiotics for the prevention of necrotising enterocolitis in very low-birth-weight infants: a meta-analysis and systematic review. Acta Paediatr. 2017 Nov;106(11):1729-1741. doi: 10.1111/apa.13902. Epub 2017 Jun 9.
Results publication: PubMed 26611880Baucells BJ, Mercadal Hally M, Alvarez Sanchez AT, Figueras Aloy J. [Probiotic associations in the prevention of necrotising enterocolitis and the reduction of late-onset sepsis and neonatal mortality in preterm infants under 1,500g: A systematic review]. An Pediatr (Barc). 2016 Nov;85(5):247-255. doi: 10.1016/j.anpedi.2015.07.038. Epub 2015 Nov 21. Spanish.
Results publication: PubMed 31593123Bi LW, Yan BL, Yang QY, Li MM, Cui HL. Which is the best probiotic treatment strategy to prevent the necrotizing enterocolitis in premature infants: A network meta-analysis revealing the efficacy and safety. Medicine (Baltimore). 2019 Oct;98(41):e17521. doi: 10.1097/MD.0000000000017521.
Results publication: PubMed 32332478van den Akker CHP, van Goudoever JB, Shamir R, Domellof M, Embleton ND, Hojsak I, Lapillonne A, Mihatsch WA, Berni Canani R, Bronsky J, Campoy C, Fewtrell MS, Fidler Mis N, Guarino A, Hulst JM, Indrio F, Kolacek S, Orel R, Vandenplas Y, Weizman Z, Szajewska H. Probiotics and Preterm Infants: A Position Paper by the European Society for Paediatric Gastroenterology Hepatology and Nutrition Committee on Nutrition and the European Society for Paediatric Gastroenterology Hepatology and Nutrition Working Group for Probiotics and Prebiotics. J Pediatr Gastroenterol Nutr. 2020 May;70(5):664-680. doi: 10.1097/MPG.0000000000002655.
Results publication: PubMed 21412889Alfaleh K, Anabrees J, Bassler D, Al-Kharfi T. Probiotics for prevention of necrotizing enterocolitis in preterm infants. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD005496. doi: 10.1002/14651858.CD005496.pub3.
Results publication: PubMed 10933736Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med. 2000 Aug 10;343(6):378-84. doi: 10.1056/NEJM200008103430601.
Individual participant dataSharing planned: No

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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.

Benjamin James Baucells, MD principal investigator

Neonataology Service, BCNatal Hospital Clínic

Giorgia Sebastiani principal investigator

Neonatology Service, BCNatal Hospital Clínic

1 site 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 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2023. 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?

This study is still under way. Results are not available in the source record yet.

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?

Degree of neurodevelopment at 24 months corrected age (time frame: 24 months). The study lists 8 primary outcomes in all. 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 NCT05945017, which also lists 24 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 14 Aug 2023.