Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

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

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

Study Overview

• Status: Completed
• Conditions: Infant, Newborn, Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 248

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 minutes to 30 minutes (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

healthy newborns

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
observational; healthy newborns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
normal levels of lamellar body counts on gastric aspirate in healthy term newborns.	2 months

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 14/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED