Trial · NCT05340465
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Ferritin at 35-36 weeks PMA | birth to 36 weeks postmenstrual age | Plasma ferritin is measured every 2 weeks in the NICU. Ferritin at 35-36 weeks will be compared between the 5 treatment groups |
| Primary | Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | Number of IV iron doses required to maintain a ferritin level of \> 75 ng/mL will be compared in the 4 IV treatment arms |
| Primary | Number of Blood transfusions | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | The number of blood transfusions received by infants in each group will be compared. |
| Primary | Volume of blood transfusions | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | The volume of blood transfused to infants in each group will be compared |
| Secondary | Number and percent of patients per group that remain transfusion free | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | Number and percent of patients per group that remain transfusion free will be compared by group |
| Secondary | Hematocrit | Birth to 36 weeks PMA | Hematocrit (lowest, highest, mean) by group to 35-36 weeks PMA |
| Secondary | Safety of IV iron | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | Any evidence of anaphylaxis will be documented during and after the first IV infusion of iron |
| Secondary | Early gut microbiome comparison between study groups | at 7 days (prior to iron supplementation) and 4 weeks after birth | Stool samples will be collected for 16S amplicon sequencing and targeted culturomics. Organism types will be compared between groups prior to and 3 weeks after the first IV iron dose. |
| Secondary | Rate of referral for Brainstem auditory evoked response | at hospital discharge, near 36 weeks postmenstrual age | Any latency in Brainstem auditory evoked response will be assessed and compared between study arms |
| Secondary | Rate of pass/fail the General Movements Assessments (GMA) | 3 months corrected age | General Movements Assessments (GMA) will be assessed at 3 months corrected age, and results compared between study arms. |
| Secondary | Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups | 6 months corrected age | Parent questionnaire (WIDEA-FS) to assess neurodevelopment will be done at 6 months corrected age. Mean and median scores will be compared by treatment arm. The WIDEA includes 50 items with a maximum score of 200. Higher scores indicate more advanced neurodevelopmental functioning. |
| Secondary | Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups | 18 months corrected age | Parent questionnaire (WIDEA-FS) to assess neurodevelopment will be done at 6 months corrected age. Mean and median scores will be compared by treatment arm. The WIDEA includes 50 items with a maximum score of 200. Higher scores indicate more advanced neurodevelopmental functioning. |
| Secondary | Late gut microbiome comparison between study groups | at 1 and 2 years corrected age. | Stool samples will be collected for 16S amplicon sequencing and targeted culturomics. Organism types will be compared between groups. If differences in early microbiome (at 4 weeks of age) are noted, we will evaluate whether they persist at 1 and 2 years of age. |
| Secondary | Neurodevelopmental outcome as assessed by the Bayley Scales of Infant Development edition-IV (BSID-IV) | 1 year and 2 years corrected age | Bayley Scales of Infant Development edition-IV (BSID-IV) will be assessed in all enrolled patients at one and two years corrected age. Results for the treatment arms will be compared. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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