Respiratory Distress Syndrome
Conditions
Keywords
vitamin D, Respiratory distress syndrome, sepsis, preterm
Brief 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.
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.
Interventions
None listed
Sponsors
Dr. Sami Ulus Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Days
Healthy volunteers
No
Inclusion criteria
* infants \<32 weeks of gestational age
Exclusion criteria
* infants with major congenital abnormality * infants \>32 weeks of gestational age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Distress Syndrome | three days | The association of vitamin D level with respiratory distress syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis | four weeks | Association of vitamin D level with sepsis |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Vitamin D Level The premature infants with low cord blood vitamin D level | 57 |
| Normal Vitamin D The premature infants with normal vitamin D level | 24 |
| Total | 81 |
Baseline characteristics
| Characteristic | Low Vitamin D Level | Normal Vitamin D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 24 Participants | 81 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 27.9 weeks STANDARD_DEVIATION 2.4 | 29.2 weeks STANDARD_DEVIATION 1.8 | 28.3 weeks STANDARD_DEVIATION 3.6 |
| Region of Enrollment Turkey | 57 participants | 24 participants | 81 participants |
| Sex: Female, Male Female | 33 Participants | 12 Participants | 45 Participants |
| Sex: Female, Male Male | 24 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 24 |
| serious Total, serious adverse events | 0 / 57 | 0 / 24 |
Outcome results
Primary
Respiratory Distress Syndrome
The association of vitamin D level with respiratory distress syndrome
Time frame: three days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Vitamin D Level | Respiratory Distress Syndrome | 52 participants |
| Normal Vitamin D | Respiratory Distress Syndrome | 3 participants |
Secondary
Sepsis
Association of vitamin D level with sepsis
Time frame: four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Vitamin D Level | Sepsis | 18 participants |
| Normal Vitamin D | Sepsis | 3 participants |