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Completed

NCT Number: NCT00971555

Thyroid Function in Late Preterm Infants

Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. T4 levels in very low birth weight infants born prematurely has been found to be inversely correlated to severity of illness. In very low birth weight infants, TH has been associated with poor outcomes. Little is known about thyroid function in late preterm infants.

Hypotheses:

1. Ill late preterm infants will have lower total T4 levels than healthy late preterm infants. 2. Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes. 3. Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.

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Key information

Conditions

Transient Hypothyroxinemia

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Hospital

Newark, Delaware, 19718, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital

Exclusion criteria

  • outborn infants
  • infants with major congenital anomalies

Treatment and study plan

Primary outcomes

  1. Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.

    Time frame: First week of life

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2009
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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