Iron DeficiencyNCT00675337
Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study
A study testing perineum maintained and abdominal placement in people with Iron Deficiency and Anemia, run by Davison, James, D.O..
Trial summary
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anemia
- What is being tested?
- perineum maintained and abdominal placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Apr 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy pregnant women
- 37 - 42 weeks of gestation
- vaginal delivery
- prenatal care initiated prior to 20 weeks of gestation
Who cannot join
- maternal diabetes
- intrauterine growth restriction
- hypertensive disorders of pregnancy
- chronic hypertension requiring medical therapy
- Apgar score less than 7 at 5 minutes
- unusual bleeding prior to delivery
Show all 9Show fewer
- alloimmunization
- maternal hemoglobinopathy
- need for immediate infant resuscitation preventing adherence to protocol
About this study
Official title: The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.
- Conditions
- Iron Deficiency, Anemia
- Being tested
- perineum maintained, abdominal placement
- Keywords
- iron stores, anemia, iron deficiency, infancy, placental transfusion, iron deficiency in infancy, anemia in infancy, placement of neonate
- Medical subject headings
- Iron Deficiencies, Anemia, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineum maintainedProcedure or surgery
infants maintained at the level of the perineum until umbilical cord clamping
abdominal placementProcedure or surgery
infants placed on the maternal abdomen prior to umbilical cord clamping
| Study group | Role | What they receive |
|---|---|---|
| perineum | Active comparator | infants maintained at the level of the perineum until umbilical cord clamping Receives: Procedure: perineum maintained |
| abdomen | Experimental | infants placed on the maternal abdomen prior to cord clamping Receives: Procedure: abdominal placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum ferritin level at 4 months of age
Measured: 4 months
Secondary outcomes (3)
blood parameters (hemoglobin and hematocrit)
Measured: 2 months and 4 months
serum ferritin at 2 months
Measured: 2 months
blood parameters (hemoglobin and hematocrit) at 24 hrs of age
Measured: 24 hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Davison, James, D.O.
- Investigators
- James M Davison, DO, Principal investigator, Warren General HospitalSunny A Thomas, MD, Principal investigator, Warren General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675337
- Sponsor's protocol ID
- wghjmd1
- Status last verified
- Dec 2008
- First submitted
- 7 May 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lozoff B, Beard J, Connor J, Barbara F, Georgieff M, Schallert T. Long-lasting neural and behavioral effects of iron deficiency in infancy. Nutr Rev. 2006 May;64(5 Pt 2):S34-43; discussion S72-91. doi: 10.1301/nr.2006.may.s34-s43.
PubMed 16770951Lozoff B, Georgieff MK. Iron deficiency and brain development. Semin Pediatr Neurol. 2006 Sep;13(3):158-65. doi: 10.1016/j.spen.2006.08.004.
PubMed 17101454Grant CC, Wall CR, Brewster D, Nicholson R, Whitehall J, Super L, Pitcher L. Policy statement on iron deficiency in pre-school-aged children. J Paediatr Child Health. 2007 Jul-Aug;43(7-8):513-21. doi: 10.1111/j.1440-1754.2007.01128.x.
PubMed 17635678Beard J. Recent evidence from human and animal studies regarding iron status and infant development. J Nutr. 2007 Feb;137(2):524S-530S. doi: 10.1093/jn/137.2.524S.
PubMed 17237340McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007 Apr;85(4):931-45. doi: 10.1093/ajcn/85.4.931.
PubMed 17413089Burden MJ, Westerlund AJ, Armony-Sivan R, Nelson CA, Jacobson SW, Lozoff B, Angelilli ML, Jacobson JL. An event-related potential study of attention and recognition memory in infants with iron-deficiency anemia. Pediatrics. 2007 Aug;120(2):e336-45. doi: 10.1542/peds.2006-2525.
PubMed 17671043Walter T. Effect of iron-deficiency anemia on cognitive skills and neuromaturation in infancy and childhood. Food Nutr Bull. 2003 Dec;24(4 Suppl):S104-10. doi: 10.1177/15648265030244S207.
PubMed 17016952Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7. doi: 10.1515/JPM.2006.056.
PubMed 16856818Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
PubMed 16567393Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
PubMed 17374818Yao AC, Lind J. Effect of gravity on placental transfusion. Lancet. 1969 Sep 6;2(7619):505-8. doi: 10.1016/s0140-6736(69)90213-x. No abstract available.
PubMed 4184835Grisaru D, Deutsch V, Pick M, Fait G, Lessing JB, Dollberg S, Eldor A. Placing the newborn on the maternal abdomen after delivery increases the volume and CD34 cell content in the umbilical cord blood collected: an old maneuver with new applications. Am J Obstet Gynecol. 1999 May;180(5):1240-3. doi: 10.1016/s0002-9378(99)70623-x.
PubMed 10329884Pafumi C, Zizza G, Russo A, Farina M, Pernicone G, Bandiera S, Giardina P, Mangiafico L, Mancari R, Maggi I, Calogero AE, Cianci A. Placing the newborn on the maternal abdomen increases the volume of umbilical cord blood collected. Clin Lab Haematol. 2001 Dec;23(6):397-9. doi: 10.1046/j.1365-2257.2001.00377.x.
PubMed 11843888Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. doi: 10.1001/archpedi.1974.02110200130021. No abstract available.
PubMed 4588934Mercer JS, Nelson CC, Skovgaard RL. Umbilical cord clamping: beliefs and practices of American nurse-midwives. J Midwifery Womens Health. 2000 Jan-Feb;45(1):58-66. doi: 10.1016/s1526-9523(99)00004-5.
PubMed 10772736
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study
- ClinicalTrials.gov ID
- NCT00675337
- Acronym / sponsor ID
- wghjmd1
- Conditions
- Iron Deficiency, Anemia
- Keywords
- iron stores, anemia, iron deficiency, infancy, placental transfusion, iron deficiency in infancy, anemia in infancy, placement of neonate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Davison, James, D.O.
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (estimated)
- First posted
- 9 May 2008 (estimated)
- 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.
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineum | Active comparator | Procedure: perineum maintainedinfants maintained at the level of the perineum until umbilical cord clamping |
| abdomen | Experimental | Procedure: abdominal placementinfants placed on the maternal abdomen prior to cord clamping |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- healthy pregnant women
- 37 - 42 weeks of gestation
- vaginal delivery
- prenatal care initiated prior to 20 weeks of gestation
Key exclusion criteria (9 listed)
- maternal diabetes
- intrauterine growth restriction
- hypertensive disorders of pregnancy
- chronic hypertension requiring medical therapy
- Apgar score less than 7 at 5 minutes
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 |
|---|---|---|
| perineum maintainedinfants maintained at the level of the perineum until umbilical cord clamping | Procedure or surgery | perineum |
| abdominal placementinfants placed on the maternal abdomen prior to umbilical cord clamping | Procedure or surgery | abdomen |
Primary outcome
serum ferritin level at 4 months of age
Time frame: 4 months
3 secondary outcomes
blood parameters (hemoglobin and hematocrit)
Time frame: 2 months and 4 months
serum ferritin at 2 months
Time frame: 2 months
blood parameters (hemoglobin and hematocrit) at 24 hrs of age
Time frame: 24 hrs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Background: PubMed 16770951Lozoff B, Beard J, Connor J, Barbara F, Georgieff M, Schallert T. Long-lasting neural and behavioral effects of iron deficiency in infancy. Nutr Rev. 2006 May;64(5 Pt 2):S34-43; discussion S72-91. doi: 10.1301/nr.2006.may.s34-s43.
- Background: PubMed 17101454Lozoff B, Georgieff MK. Iron deficiency and brain development. Semin Pediatr Neurol. 2006 Sep;13(3):158-65. doi: 10.1016/j.spen.2006.08.004.
- Background: PubMed 17635678Grant CC, Wall CR, Brewster D, Nicholson R, Whitehall J, Super L, Pitcher L. Policy statement on iron deficiency in pre-school-aged children. J Paediatr Child Health. 2007 Jul-Aug;43(7-8):513-21. doi: 10.1111/j.1440-1754.2007.01128.x.
- Background: PubMed 17237340Beard J. Recent evidence from human and animal studies regarding iron status and infant development. J Nutr. 2007 Feb;137(2):524S-530S. doi: 10.1093/jn/137.2.524S.
- Background: PubMed 17413089McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007 Apr;85(4):931-45. doi: 10.1093/ajcn/85.4.931.
- Background: PubMed 17671043Burden MJ, Westerlund AJ, Armony-Sivan R, Nelson CA, Jacobson SW, Lozoff B, Angelilli ML, Jacobson JL. An event-related potential study of attention and recognition memory in infants with iron-deficiency anemia. Pediatrics. 2007 Aug;120(2):e336-45. doi: 10.1542/peds.2006-2525.
- Background: PubMed 17016952Walter T. Effect of iron-deficiency anemia on cognitive skills and neuromaturation in infancy and childhood. Food Nutr Bull. 2003 Dec;24(4 Suppl):S104-10. doi: 10.1177/15648265030244S207.
- Background: PubMed 16856818Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7. doi: 10.1515/JPM.2006.056.
- Background: PubMed 16567393Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
- Background: PubMed 17374818Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
- Background: PubMed 4184835Yao AC, Lind J. Effect of gravity on placental transfusion. Lancet. 1969 Sep 6;2(7619):505-8. doi: 10.1016/s0140-6736(69)90213-x. No abstract available.
- Background: PubMed 10329884Grisaru D, Deutsch V, Pick M, Fait G, Lessing JB, Dollberg S, Eldor A. Placing the newborn on the maternal abdomen after delivery increases the volume and CD34 cell content in the umbilical cord blood collected: an old maneuver with new applications. Am J Obstet Gynecol. 1999 May;180(5):1240-3. doi: 10.1016/s0002-9378(99)70623-x.
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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.
James M Davison, DO principal investigator
Warren General Hospital
Sunny A Thomas, MD principal investigator
Warren General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing perineum maintained and abdominal placement in people with Iron Deficiency and Anemia, run by Davison, James, D.O..
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 4 inclusion and 9 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 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
serum ferritin level at 4 months of age (time frame: 4 months). 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 NCT00675337, which also lists 17 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 31 Dec 2008.