The Effect of Maternal and Neonatal Vitamin D Levels on Respiratory Distress Syndrome in Preterm Infants

NCT02024490 | Completed DMC

• 1 other identifier: MC10001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory distress syndrome (RDS) of the newborn, also called as hyaline membrane disease, is the most common cause of respiratory distress in premature infants, correlating with structural and functional lung immaturity. The pathophysiology of RDS is complex. Immature type II alveolar cells produce less surfactant that causes an increase in alveolar surface tension and a decrease in compliance. This resultant atelectasis lead to pulmonary vascular constriction, hypoperfusion, and lung tissue ischemia. RDS and prolonged ventilation and associated systemic/lung injury may also contribute to long term oxygen dependency and may result in bronchopulmonary dysplasia (BPD). Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In addition to its classical role in bone metabolism, vitamin D deficiency has been associated with impaired pulmonary function, increased incidence of viral and bacterial infections and inflammatory lung diseases. Although exact mechanisms are not fully understood, vitamin D appears to impact on a variety of inflammatory and structural cells within the lung including macrophages, lymphocytes and epithelial cells. To our best of knowledge, no study has evaluated the effect of vitamin D levels on the severity and presence of RDS in preterm infants. Therefore, the aim of this study is to evaluate the possible role of maternal/neonatal vitamin D levels on RDS development in preterm infants. We also aim to determine the possible association between maternal/neonatal vitamin D levels and the incidence of BPD and other neonatal morbidities.

Conditions

Vitamin D Deficiency

Keywords

vitamin D, prematurity, RDS, BPD, maternal, neonatal

Outcome Measures

Primary Outcomes (1)

• development of respiratory distress in infants according to vitamin D levels

  A total of 100 preterm infants will be included and vitamin D levels will be compared between those with and without respiratory distress syndrome

  1 year

Secondary Outcomes (1)

• presence of vitamin D deficiency and bronchopulmonary dysplasia

  1 year

Other Outcomes (1)

• development of prematurity morbidities

  1year

Study Arms (1)

RDS group, non-RDS group

RDS group; infants with clinical, radiological and laboratory findings of RDS non-RDS group; infants without clinical, radiological and laboratory findings of RDS

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature infants admitted to neonatal intesive care unit with the diagnosis of respiratory distress syndrome (RDS) will constitute the RDS group, whereas preterm infants without RDS will constitute the non-RDS group

You may qualify if:

• Preterm infants \<37 weeks of gestational age and are admitted to Neonatal Intensive Care Unit of Kanuni Sultan Suleyman Training and Research Hospital
• Preterm infants with clinical and laboratory findings of RDS

You may not qualify if:

• presence of maternal clinical and/or histological chorioamnionitis,
• presence of premature rupture of membranes (PROM),
• refusal of parental consent,
• lack of laboratory data,
• major congenital abnormalities

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Stanbul, 34052, Turkey (Türkiye)

Location

Related Publications (3)

• Parekh D, Thickett DR, Turner AM. Vitamin D deficiency and acute lung injury. Inflamm Allergy Drug Targets. 2013 Aug;12(4):253-61. doi: 10.2174/18715281113129990049.

  PMID: 23782208 BACKGROUND

• Gupta A, Bush A, Hawrylowicz C, Saglani S. Vitamin D and asthma in children. Paediatr Respir Rev. 2012 Dec;13(4):236-43; quiz 243. doi: 10.1016/j.prrv.2011.07.003. Epub 2011 Sep 1.

  PMID: 23069123 BACKGROUND

• Bener A, Ehlayel MS, Tulic MK, Hamid Q. Vitamin D deficiency as a strong predictor of asthma in children. Int Arch Allergy Immunol. 2012;157(2):168-75. doi: 10.1159/000323941. Epub 2011 Oct 6.

  PMID: 21986034 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Premature Birth

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Merih Cetinkaya, MD, PhD

  Kanuni Sultan Suleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

TU (1)