Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)

NCT06555315 | Recruiting

• 1 other identifier: 2024-091
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

Conditions

Very Low Birth Weight Infant; Premature Infants; Anemia of Prematurity; Iron Deficiency, Anaemia in Children; Extremely Low Birth Weight

Keywords

Premature infants; Iron; anemia of prematurity; iron deficiency

Outcome Measures

Primary Outcomes (1)

• Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA.

  The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation.

  1 Week-36 Weeks

Secondary Outcomes (6)

• Characterize Ret-Hb levels in preterm infants.

  12-24 Months

• Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.

  12-24 Months

• Determine prevalence of bronchopulmonary dysplasia between two groups.

  12-24 Months

• Identify the number of subjects with sepsis between two groups.

  12-24 Months

• Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.

  12-24 Months

Study Arms (2)

Control Group

OTHER

After the infant achieves full enteral feeds, the infant is started on 6 mg/kg of oral iron daily supplementation. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status.

Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every day.

Intervention Group

EXPERIMENTAL

After the infant achieves full enteral feeds, the infant is started on 6mg/kg of oral iron supplementation administered every other day. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status.

Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every other day.

Interventions

6 mg/kg of oral iron as ferrous sulfate administered every other day. DIETARY_SUPPLEMENT

6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.

Intervention Group

6 mg/kg of oral iron as ferrous sulfate administered every day. DIETARY_SUPPLEMENT

6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.

Control Group

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children (Minor \< 18 years of age)
• Neonates
• Hospitalized
• Premature infants who are on full enteral feeds and are started on oral iron
• Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth

You may not qualify if:

• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Children's

San Antonio, Texas, 78207, United States

RECRUITING

Related Publications (14)

• Sriranjan J, Kalata C, Fusch G, Thomas K, Goswami I. Prevalence and Implications of Low Reticulocyte-Hemoglobin Levels among Extreme Preterm Neonates: A Single-Center Retrospective Study. Nutrients. 2022 Dec 16;14(24):5343. doi: 10.3390/nu14245343.

  PMID: 36558502 RESULT

• Wang Y, Wu Y, Li T, Wang X, Zhu C. Iron Metabolism and Brain Development in Premature Infants. Front Physiol. 2019 Apr 25;10:463. doi: 10.3389/fphys.2019.00463. eCollection 2019.

  PMID: 31105583 RESULT

• McCarthy EK, Dempsey EM, Kiely ME. Iron supplementation in preterm and low-birth-weight infants: a systematic review of intervention studies. Nutr Rev. 2019 Dec 1;77(12):865-877. doi: 10.1093/nutrit/nuz051.

  PMID: 31532494 RESULT

• Nii M, Okamoto T, Sugiyama T, Aoyama A, Nagaya K. Reticulocyte hemoglobin content changes after treatment of anemia of prematurity. Pediatr Int. 2022 Jan;64(1):e15330. doi: 10.1111/ped.15330.

  PMID: 36321339 RESULT

• Puia-Dumitrescu M, Tanaka DT, Spears TG, Daniel CJ, Kumar KR, Athavale K, Juul SE, Smith PB. Patterns of phlebotomy blood loss and transfusions in extremely low birth weight infants. J Perinatol. 2019 Dec;39(12):1670-1675. doi: 10.1038/s41372-019-0515-6. Epub 2019 Oct 3.

  PMID: 31582812 RESULT

• Bahr TM, Tan S, Smith E, Beauman SS, Schibler KR, Grisby CA, Lowe JR, Bell EF, Laptook AR, Shankaran S, Carlton DP, Rau C, Baserga MC, Flibotte J, Zaterka-Baxter K, Walsh MC, Das A, Christensen RD, Ohls RK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not correlate with reticulocyte hemoglobin content. J Perinatol. 2023 Nov;43(11):1368-1373. doi: 10.1038/s41372-023-01751-z. Epub 2023 Aug 18.

  PMID: 37596391 RESULT

• Karakoc G, Orgul G, Sahin D, Yucel A. Is every other day iron supplementation effective for the treatment of the iron deficiency anemia in pregnancy? J Matern Fetal Neonatal Med. 2022 Mar;35(5):832-836. doi: 10.1080/14767058.2021.1910666. Epub 2021 Apr 18.

  PMID: 33866933 RESULT

• Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.

  PMID: 31413088 RESULT

• von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.

  PMID: 38021373 RESULT

• Pasupathy E, Kandasamy R, Thomas K, Basheer A. Alternate day versus daily oral iron for treatment of iron deficiency anemia: a randomized controlled trial. Sci Rep. 2023 Feb 1;13(1):1818. doi: 10.1038/s41598-023-29034-9.

  PMID: 36725875 RESULT

• German KR, Comstock BA, Parikh P, Whittington D, Mayock DE, Heagerty PJ, Bahr TM, Juul SE. Do Extremely Low Gestational Age Neonates Regulate Iron Absorption via Hepcidin? J Pediatr. 2022 Feb;241:62-67.e1. doi: 10.1016/j.jpeds.2021.09.059. Epub 2021 Oct 7.

  PMID: 34626672 RESULT

• Uyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.

  PMID: 32678434 RESULT

• Manapurath RM, Gadapani Pathak B, Sinha B, Upadhyay RP, Choudhary TS, Chandola TR, Mazumdar S, Taneja S, Bhandari N, Chowdhury R. Enteral Iron Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis. Pediatrics. 2022 Aug 1;150(Suppl 1):e2022057092I. doi: 10.1542/peds.2022-057092I.

  PMID: 35921671 RESULT

• MacQueen BC, Baer VL, Scott DM, Ling CY, O'Brien EA, Boyer C, Henry E, Fleming RE, Christensen RD. Iron Supplements for Infants at Risk for Iron Deficiency. Glob Pediatr Health. 2017 Apr 25;4:2333794X17703836. doi: 10.1177/2333794X17703836. eCollection 2017.

  PMID: 28491927 RESULT

MeSH Terms

Conditions

Premature Birth; Anemia; Iron Deficiencies

Interventions

Iron

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Pratik K Parikh, MD

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

• Richelle L Homo, MD

  CHRISTUS Health; Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosario Ocampo

CONTACT

210-704-4996; rosario.ocampo@christushealth.org

Donna Rodney

CONTACT

(210) 683-7746; donna.rodney@christushealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A statistician who is blinded to the study allocation will analyze the data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 15, 2024
• Study Start: August 1, 2024
• Primary Completion: March 28, 2026
• Study Completion: March 28, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)