Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) (PREMOD2FU)
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|ClinicalTrials.gov Identifier: NCT03476980|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neurodevelopmental Abnormality||Procedure: Randomized to Umbilical Cord Milking at birth Procedure: Randomized to Delayed Cord Clamping at birth||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.|
|Official Title:||Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Active Comparator: Randomized to Umbilical Cord Milking at birth
Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.
Procedure: Randomized to Umbilical Cord Milking at birth
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.
Other Name: UCM
Active Comparator: Randomized to Delayed Cord Clamping at birth
Delayed clamping of the umbilical cord at birth.
Procedure: Randomized to Delayed Cord Clamping at birth
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.
Other Name: DCC
- NeuroDevelopmental Outcome [ Time Frame: 22-26 months corrected gestational age ]Bayley 3 Composite Score (motor, cognitive, language)
- Moderate/Severe Neurodevelopmental Impairment [ Time Frame: 22-26 months corrected gestational age ]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.
- Mild Neurodevelopmental Impairment [ Time Frame: 22-26 months corrected gestational age ]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.
- Cerebral Palsy [ Time Frame: 22-26 months corrected gestational age ]Classified as None, Mild, Moderate or Severe based on GMFCS score
- Neurological Function [ Time Frame: 22-26 months corrected gestational age ]A clinical practitioner will perform a Physical Exam. The neurologic assessment includes assessment of vision, hearing, muscle tone, movements, reflexes, hand function. These will be classified as Normal, Suspect or Abnormal.
- Gross Motor Function Classification Scale (GMFCS) [ Time Frame: 22-26 months corrected gestational age ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476980
|Contact: Anup Katheria, MD||858 email@example.com|
|Contact: Jane Steen, RN||858 939-4114|
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294-0004|
|United States, California|
|Loma Linda Medical Center|
|Loma Linda, California, United States, 92350|
|Sharp Grossmont Hospital||Recruiting|
|San Diego, California, United States, 91942|
|Contact: Kevin Fulford, MD firstname.lastname@example.org|
|Sharp Mary Birch Hospital for Women and Newborns|
|San Diego, California, United States, 92123|
|United States, Delaware|
|Newark, Delaware, United States, 19718|
|United States, Oregon|
|Providence St. Vincent Medical Center|
|Portland, Oregon, United States, 97225-6603|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Erin Clark, MD email@example.com|
|Contact: Tara DuPont, MD firstname.lastname@example.org|
|Governors of University of Alberta|
|Edmonton, Alberta, Canada, T6G 2R3|
|University of ULM|
|Ulm, Baden-Wurttemberg, Germany, 89075|
|Cork University Maternity Hospital|
|Principal Investigator:||Anup Katheria, MD||Sharp Mary Birch Hospital for Women & Newborns|