Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities

NCT01812681 — Completed, 81 participants, Dr. Sami Ulus Children's Hospital

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Is Higher Cord Blood 25(Oh)-Vitamin D Level Preventive For Any Morbidity Including Rds, Pda, Nec, Bpd And Rop In Preterm Infants

Registry	NCT01812681
Status	Completed
Study type	Observational
Enrollment	81 (Actual)
Sponsor	Dr. Sami Ulus Children's Hospital (Other)
Conditions	Respiratory Distress Syndrome
Dates	start 2012-10-01, primary completion 2013-10-01, completion 2013-11-01, first posted 2013-03-18, last updated 2014-08-15
Locations	1 site in Turkey (Türkiye)

-Summary

Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

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+Detailed description

It was shown that vitamin D play important role in the pathogenesis of long term morbidities of newborn. Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

+Arms and interventions

Arm	Type	Interventions	Description
Low vitamin D level			The premature infants with low cord blood vitamin D level
Normal Vitamin D			The premature infants with normal vitamin D level

+Outcome measures

Primary outcomes

Respiratory Distress Syndrome [three days]: The association of vitamin D level with respiratory distress syndrome

Secondary outcomes

Sepsis [four weeks]: Association of vitamin D level with sepsis

+Eligibility

Sex: All, ages: 1 Day to 5 Days

Inclusion Criteria:

* infants <32 weeks of gestational age

Exclusion Criteria:

* infants with major congenital abnormality
* infants >32 weeks of gestational age

+Posted results

Participant flow

Milestone	Low Vitamin D Level	Normal Vitamin D
Started	60	24
Completed	57	24
Not completed	3	0

Outcome results

Respiratory Distress Syndrome (Primary), Number, participants: Low Vitamin D Level 52; Normal Vitamin D 3
Sepsis (Secondary), Number, participants: Low Vitamin D Level 18; Normal Vitamin D 3

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Low Vitamin D Level	0	0/57 (0.0%)	0/57 (0.0%)
Normal Vitamin D	0	0/24 (0.0%)	0/24 (0.0%)

+Locations (1)

Facility	City	Country	Status
Sami Ulus CH	Ankara	Turkey (Türkiye)

+Publications

Grant WB. Vitamin D supplementation of mother and infant could reduce risk of sepsis in premature infants. Early Hum Dev. 2010 Feb;86(2):133. doi: 10.1016/j.earlhumdev.2010.02.003. Epub 2010 Feb 25. No abstract available. PMID 20188500
Results publication: Fettah ND, Zenciroglu A, Dilli D, Beken S, Okumus N. Is higher 25-hydroxyvitamin D level preventive for respiratory distress syndrome in preterm infants? Am J Perinatol. 2015 Feb;32(3):247-50. doi: 10.1055/s-0034-1383849. Epub 2014 Sep 13. PMID 25217734

+Investigators

Dilek Dilli, Assoc Prof, Study director, Sami Ulus CH