NCT01149928

Brief Summary

In this prospective, cross-sectional study, the aim was to investigate the possible role of cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4, and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed
Last Updated

June 24, 2010

Status Verified

October 1, 2009

Enrollment Period

11 months

First QC Date

June 21, 2010

Last Update Submit

June 23, 2010

Conditions

Keywords

Fetal lung fluidPulmonary adaptationTransient tachypnea of the newbornEpinephrineStress hormones

Outcome Measures

Primary Outcomes (1)

  • Stress response at birth, as demonstrated by cord cortisol, adrenocorticotropic hormone, epinephrine, fT3, fT4, and thyroid-stimulating hormone in late preterm and term neonates developing transient tachypnea of the newborn.

    At birth cord blood samples and perinatal data were collected from ceseraen deliveries of late preterm and term infants. Cord stress hormones of the infants with the diagnosis of TTN and gestational age matched controls were analyzed.

    postnatal first 24 hours

Study Arms (2)

C/S delivered, wet lung

C/S delivered, healthy infants

Eligibility Criteria

Age34 Weeks - 40 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Cesarean delivered, late preterm and term infants during the study period in Maternity Center of Ankara University

You may qualify if:

  • Gestation age \> 34 weeks
  • C/S delivered infants
  • Parental consent form signed

You may not qualify if:

  • Gestation age \< 34 weeks
  • Maternal conditions that compromised fetal well-being (hypertensive disorder, diabetes, chorioamnionitis)
  • Intrauterine growth retardation
  • Congenital malformations
  • Absence of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Atasay B, Ergun H, Okulu E, Mungan Akin I, Arsan S. The association between cord hormones and transient tachypnea of newborn in late preterm and term neonates who were delivered by cesarean section. J Matern Fetal Neonatal Med. 2013 Jun;26(9):877-80. doi: 10.3109/14767058.2013.765846. Epub 2013 Feb 8.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood serum samples were stored.

MeSH Terms

Conditions

Pulmonary EdemaTransient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory Distress Syndrome, NewbornRespiratory Distress SyndromeRespiration DisordersTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 24, 2010

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

June 24, 2010

Record last verified: 2009-10