In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants

In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight (ELBW) Infants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01203501

Acronym

MgSO4

Enrollment

1339

Registered

2010-09-16

Start date

1996-07-31

Completion date

2000-06-30

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Intracranial Hemorrhages, Leukomalacia, Periventricular

Keywords

NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Antenatal Magnesium sulfate

Brief summary

This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).

Detailed description

Retrospective studies suggested that the risk of cerebral palsy and intraventricular hemorrhage (IVH) in extremely premature infants of mothers given magnesium sulfate (MgSO4) may be reduced. The purpose of this study was to examine the effects of MgSO4 exposure on adverse outcomes in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database, data were prospectively collected on maternal/infant conditions and MgSO4 exposure (including indications, timing and duration of exposure).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

Healthy volunteers

Yes

Inclusion criteria

* Infants born in NRN Centers with a birth weight of 401-1,500g

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Incidence of Intraventricular Hemorrhage	Hospital discharge 120 days of life

Secondary

Measure	Time frame
Incidence of cerebral palsy	18-22 months corrected age

Countries

United States

Outcome results