Neurodevelopmental AbnormalityPREMOD2FUNCT03476980
Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
A study testing Randomized to Umbilical Cord Milking at birth and Randomized to Delayed Cord Clamping at birth in people with Neurodevelopmental Abnormality, run by Sharp HealthCare at 18 sites in 4 countries.
Trial summary
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. Read more about this study
- Who is it for?
- Ages 22 to 42 months
- Conditions the study is for
- Neurodevelopmental Abnormality
- What is being tested?
- Randomized to Umbilical Cord Milking at birth and Randomized to Delayed Cord Clamping at birth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 6 Jul 2019to Dec 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 22 to 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
Who cannot join
- Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
Trial locations and contacts
18 sites in 4 countries.
Jane Steen, RN contact
18 sites in 4 countries
United States15 sites, 15 recruiting
- Recruiting
University of Alabama
Birmingham, Alabama, 35294-0004
Wally Carlo, MD, wcarlo@peds.uab.edu
- Recruiting
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612
Janardhan Mydam, MD, jmydam@cookcountyhhs.org
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Vivek Narendran, MD, vivek.narendran@cchmc.org
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Simon Karam, MD, skaram@umc.edu
Rachael Morris, MD, rmorris@umc.edu
- Recruiting
Loma Linda Medical Center
Loma Linda, California, 92350
Farha Vora, MD, FVora@llu.edu
- Recruiting
LAC+USC Medical Center
Los Angeles, California, 90033
Fiona Wertheimer, DO, 323-409-3322
- Recruiting
PIH Health Good Samaritan Hospital
Los Angeles, California, 90033
Manoj Biniwale, MD, 323-409-3406, Biniwale@usc.edu
- Recruiting
Christiana Care
Newark, Delaware, 19718
Shazia Bhat, MD, SBhat@ChristianaCare.org
- Recruiting
University of California, Irvine Medical Center
Orange, California, 92868
Fayez Bany-Mohammed, MD, 714-456-6933, fbanymoh@hs.uci.edu
- Recruiting
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Sue Beers, PhD, beerssr@upmc.edu
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225-6603
Michele Raddish, MD, Michele.Raddish@providence.org
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Erin Clark, MD, erin.clark@hsc.utah.edu
Tara DuPont, MD, tara.dupont@hsc.utah.edu
- Recruiting
Sharp Grossmont Hospital
San Diego, California, 91942
Kevin Fulford, MD, kevin.fulford@sharp.com
- Recruiting
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
Yvonne Vaucher, MD, yvaucher@ucsd.edu
Anup Katheria, MD, anup.katheria@sharp.com
- Recruiting
St. Louis University
St Louis, Missouri, 63104
Nitin Chouthai, MD, nitin.chouthai@health.slu.edu
Canada1 site, 1 recruiting
- Recruiting
Governors of University of Alberta
Edmonton, Alberta, T6G 2R3
Matthew Hicks, MD, matt.hicks@ahs.ca
Germany1 site, 1 recruiting
- Recruiting
University of ULM
Ulm, Baden-Wurttemberg, 89075
Jochen Essers, MD, Jochen.Essers@uniklinik-ulm.de
Ireland1 site, 1 recruiting
- Recruiting
Cork University Maternity Hospital
Cork
Eugene Dempsey, MD, G.Dempsey@ucc.ie
About this study
Official title: Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
Read the detailed description
The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.
- Conditions
- Neurodevelopmental Abnormality
- Being tested
- Randomized to Umbilical Cord Milking at birth, Randomized to Delayed Cord Clamping at birth
- Keywords
- Neurodevelopmental impairment, prematurity, Disability, Umbilical cord milking, Delayed cord clamping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized to Umbilical Cord Milking at birthProcedure or surgery
Also called UCM
The subjects in this group were randomized to UCM X4 at birth. This procedure infuses a placental transfusion of blood by milking the umbilical cord towards the infant at birth.
Randomized to Delayed Cord Clamping at birthProcedure or surgery
Also called DCC
The subjects in this group were randomized to DCC at birth. At delivery, the obstetrician was instructed to delay clamping of the umbilical cord for 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Randomized to Umbilical Cord Milking at birth | Active comparator | Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth. Receives: Procedure: Randomized to Umbilical Cord Milking at birth |
| Randomized to Delayed Cord Clamping at birth | Active comparator | Delayed clamping of the umbilical cord at birth. Receives: Procedure: Randomized to Delayed Cord Clamping at birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Outcome
Bayley Scales of Infant Development (BSID), 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
Measured: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Secondary outcomes (12)
Moderate/Severe Neurodevelopmental Impairment
Defined having at least one of the following: a cognitive score <70, GMFCS greater or equal 2, blindness (vision <20/200), or hearing impairment interfering with the ability to communicate with amplification.
Measured: 22-26 months corrected gestational age
Mild Neurodevelopmental Impairment
Defined having at least one of the following: a cognitive score 70-84, GMFCS =1, unilateral blindness (vision <20/200 in only one eye), or hearing impairment which does not interfere with the ability to communicate.
Measured: 22-26 months corrected gestational age
Gross Motor Function Classification System Scale (GMFCS)
The GMFCS is a validated system used to describe the severity of motor dysfunction. Scale measured from Level 0-5 with Level 0 being normal and Level 5 being the worst score. Measures ability to walk, sit, head control, voluntary movements and postures.
Measured: 22-26 months corrected gestational age
Cerebral Palsy (CP)
Classified as None, Mild, Moderate or Severe based on GMFCS score; No CP = GMFCS Level 0, Mild CP = GMFCS Level 1, Moderate CP = GMFCS Levels 2-3, Severe CP = GMFCS Levels 4-5
Measured: 22-26 months corrected gestational age
Developmental Outcomes assessed by Ages & Stages Questionnaire, 3rd ed. (ASQ-3) five domains: Communication, Gross motor, Fine motor, Problem solving and Personal-social in infants born between 23-32+6 weeks GA who received UCM or DCC.
Each domain is scored from 0 to 60, the higher score is better.
Measured: 22-26 months corrected gestational age
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
BSID Cognitive, Language \& Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
Measured: 22-26 months corrected gestational age
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
Measured: 22-26 months corrected gestational age
Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.
Mild, moderate or severe impairment
Measured: 22-26 months corrected gestational age
Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
Any IVH grade from 1 to grade 4, higher grade is worse
Measured: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
Death
Measured: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Compare neurodevelopmental outcomes from BSID assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.
BSID Cognitive, Language \& Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
Measured: 22-26 months corrected gestational age
Compare neurodevelopmental outcomes from ASQ assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.
ASQ-3 scores (0 to 60, the higher score is better).
Measured: 22-26 months corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start6 Jul 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental AbnormalityStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Neurodevelopmental assessments will be done at 2 years of corrected age (22-26 months) for subjects who were randomized at birth to receive either delayed cord clamping or umbilical cord milking as part of the PREMOD2 trial. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns, Loma Linda University, University of Pittsburgh, Providence Hospital, University of Alabama at Birmingham, University of Alberta, University College Cork, University of Ulm, Christiana Care Health Services, Thrasher Research Fund, Sharp Grossmont Hospital, University of Utah, University of Mississippi Medical Center, PIH Health Good Samaritan Hospital, University of California, Irvine, Children's Hospital Medical Center, Cincinnati, Cook County Health, St. Louis University, LAC+USC Medical Center
- Responsible party
- Sponsor
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp Mary Birch Hospital for Women & Newborns
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476980
- Sponsor's protocol ID
- PREMOD2 Follow-Up
- Acronym
- PREMOD2FU
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2018
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
Publications
Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
PubMed 29246467Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368.
PubMed 26122803
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
- ClinicalTrials.gov ID
- NCT03476980
- Acronym / sponsor ID
- PREMOD2FU / PREMOD2 Follow-Up
- Conditions
- Neurodevelopmental Abnormality
- Keywords
- Neurodevelopmental impairment, prematurity, Disability, Umbilical cord milking, Delayed cord clamping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns, Loma Linda University, University of Pittsburgh, Providence Hospital, University of Alabama at Birmingham, University of Alberta, University College Cork, University of Ulm, Christiana Care Health Services, Thrasher Research Fund, Sharp Grossmont Hospital, University of Utah, University of Mississippi Medical Center, PIH Health Good Samaritan Hospital, University of California, Irvine, Children's Hospital Medical Center, Cincinnati, Cook County Health, St. Louis University, LAC+USC Medical Center
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Mar 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.
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
Detailed description
The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Neurodevelopmental assessments will be done at 2 years of corrected age (22-26 months) for subjects who were randomized at birth to receive either delayed cord clamping or umbilical cord milking as part of the PREMOD2 trial. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
| Arm | Type | Receives |
|---|---|---|
| Randomized to Umbilical Cord Milking at birth | Active comparator | Procedure: Randomized to Umbilical Cord Milking at birthMilking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth. |
| Randomized to Delayed Cord Clamping at birth | Active comparator | Procedure: Randomized to Delayed Cord Clamping at birthDelayed clamping of the umbilical cord at birth. |
Who may qualify
- Ages
- 22 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
Key exclusion criteria (1 listed)
- Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
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 |
|---|---|---|
| Randomized to Umbilical Cord Milking at birthAlso: UCMThe subjects in this group were randomized to UCM X4 at birth. This procedure infuses a placental transfusion of blood by milking the umbilical cord towards the infant at birth. | Procedure or surgery | Randomized to Umbilical Cord Milking at birth |
| Randomized to Delayed Cord Clamping at birthAlso: DCCThe subjects in this group were randomized to DCC at birth. At delivery, the obstetrician was instructed to delay clamping of the umbilical cord for 60 seconds. | Procedure or surgery | Randomized to Delayed Cord Clamping at birth |
Primary outcome
Developmental Outcome
Time frame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Bayley Scales of Infant Development (BSID), 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
12 secondary outcomes
Moderate/Severe Neurodevelopmental Impairment
Time frame: 22-26 months corrected gestational age
Mild Neurodevelopmental Impairment
Time frame: 22-26 months corrected gestational age
Gross Motor Function Classification System Scale (GMFCS)
Time frame: 22-26 months corrected gestational age
Cerebral Palsy (CP)
Time frame: 22-26 months corrected gestational age
Developmental Outcomes assessed by Ages & Stages Questionnaire, 3rd ed. (ASQ-3) five domains: Communication, Gross motor, Fine motor, Problem solving and Personal-social in infants born between 23-32+6 weeks GA who received UCM or DCC.
Time frame: 22-26 months corrected gestational age
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
Time frame: 22-26 months corrected gestational age
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
Time frame: 22-26 months corrected gestational age
Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.
Time frame: 22-26 months corrected gestational age
Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
Time frame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
Time frame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Compare neurodevelopmental outcomes from BSID assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.
Time frame: 22-26 months corrected gestational age
Compare neurodevelopmental outcomes from ASQ assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.
Time frame: 22-26 months corrected gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Background: PubMed 29246467Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
- Background: PubMed 26122803Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368.
- Individual participant dataSharing planned: Yes. Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
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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.
Jane Steen, RN contact
Anup Katheria, MD principal investigator
Sharp Mary Birch Hospital for Women & Newborns
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized to Umbilical Cord Milking at birth and Randomized to Delayed Cord Clamping at birth in people with Neurodevelopmental Abnormality, run by Sharp HealthCare at 18 sites in 4 countries.
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: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, Germany, Ireland. 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 Anup Katheria, MD (858 939-4170, anup.katheria@sharp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Outcome (time frame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.). 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 NCT03476980, which also lists 2 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 25 Nov 2022.