Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

Infant, Newborn, Diseases Clinical Trial

Official title:

Reference Ranges of Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865772
• Other study ID #: 14/2014
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 9, 2016
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy term newborns.

Description:

Lamellar bodies represent the storage form of lung surfactant. Surfactant is produced in alveolar type II cells and transported to the alveolar surface as lamellar bodies. Lamellar bodies are present in the amniotic fluid and also gastric aspirate.It has become a preferred test for determine fetal lung maturity, because of the rapid, inexpensive, easily accessible and easily applicable method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

Inclusion Criteria:

• infants born at = 37 weeks of gestation and birth weight = 2500 g

Exclusion Criteria:

• intubated immediately after birth, infants with respiratory distress, infants with gestational pathology that can influence fetal lung maturity (cases with premature rupture of membranes, preeclampsia/eclampsia, gestational diabetes, oligohydramnios/polyhidramnios or antenatal steroid use), infants with major congenital or chromosomal abnormalities and lack of parental consent, therapeutic infusion was given in the amniotic cavity or if gastric aspirate contaminated by meconium, pus or blood.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infant, Newborn, Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normal levels of lamellar body counts on gastric aspirate in healthy term newborns.		2 months	No