Safety of one 52-μmol (50000 IU) oral dose of vitamin A administered to neonates

T. Agoestina, Jean Hawes Humphrey, G. A. Taylor, A. Usman, D. Subardja, S. Hidayat, M. Nurachim, Lee Shu Fune Wu, David S Friedman, Keith West, Alfred Sommer

Research output: Contribution to journalArticle

Abstract

A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-μmol (50000 IU) dose of vitamin A. Infants were assessed for potential acute side-effects before and throughout 46 hours after the dose. The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index (RI) of the anterior cerebral artery using duplex Doppler. Groups were comparable at the baseline. A bulging fontanelle occurred in the control and vitamin A groups, respectively, among 2.7% and 4.6% of the infants at 24 hours, and 2.4% and 4.5% of the infants at 48 hours. The groups did not differ in any other sign or symptom assessed. No infant developed intracranial haemorrhage. Mean RI values were normal and not different between groups at baseline or at 24 hours. Mean RI fell during the 24 hours, as normally occurs; the mean decrease was nearly identical in the two groups. A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI. The 52-μmol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants, but no increase in intracranial pressure. Acute side-effects following this intervention were rare and mild.

Original languageEnglish (US)
Pages (from-to)859-868
Number of pages10
JournalBulletin of the World Health Organization
Volume72
Issue number6
StatePublished - 1994

Fingerprint

Vitamin A
Newborn Infant
Safety
Intracranial Hemorrhages
Signs and Symptoms
Anterior Cerebral Artery
Intracranial Hypertension
Reference Values
Placebos

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Safety of one 52-μmol (50000 IU) oral dose of vitamin A administered to neonates. / Agoestina, T.; Humphrey, Jean Hawes; Taylor, G. A.; Usman, A.; Subardja, D.; Hidayat, S.; Nurachim, M.; Wu, Lee Shu Fune; Friedman, David S; West, Keith; Sommer, Alfred.

In: Bulletin of the World Health Organization, Vol. 72, No. 6, 1994, p. 859-868.

Research output: Contribution to journalArticle

@article{11b8ad78035f422ca994e159287d298f,
title = "Safety of one 52-μmol (50000 IU) oral dose of vitamin A administered to neonates",
abstract = "A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-μmol (50000 IU) dose of vitamin A. Infants were assessed for potential acute side-effects before and throughout 46 hours after the dose. The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index (RI) of the anterior cerebral artery using duplex Doppler. Groups were comparable at the baseline. A bulging fontanelle occurred in the control and vitamin A groups, respectively, among 2.7{\%} and 4.6{\%} of the infants at 24 hours, and 2.4{\%} and 4.5{\%} of the infants at 48 hours. The groups did not differ in any other sign or symptom assessed. No infant developed intracranial haemorrhage. Mean RI values were normal and not different between groups at baseline or at 24 hours. Mean RI fell during the 24 hours, as normally occurs; the mean decrease was nearly identical in the two groups. A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI. The 52-μmol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants, but no increase in intracranial pressure. Acute side-effects following this intervention were rare and mild.",
author = "T. Agoestina and Humphrey, {Jean Hawes} and Taylor, {G. A.} and A. Usman and D. Subardja and S. Hidayat and M. Nurachim and Wu, {Lee Shu Fune} and Friedman, {David S} and Keith West and Alfred Sommer",
year = "1994",
language = "English (US)",
volume = "72",
pages = "859--868",
journal = "Bulletin of the World Health Organization",
issn = "0042-9686",
publisher = "World Health Organization",
number = "6",

}

TY - JOUR

T1 - Safety of one 52-μmol (50000 IU) oral dose of vitamin A administered to neonates

AU - Agoestina, T.

AU - Humphrey, Jean Hawes

AU - Taylor, G. A.

AU - Usman, A.

AU - Subardja, D.

AU - Hidayat, S.

AU - Nurachim, M.

AU - Wu, Lee Shu Fune

AU - Friedman, David S

AU - West, Keith

AU - Sommer, Alfred

PY - 1994

Y1 - 1994

N2 - A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-μmol (50000 IU) dose of vitamin A. Infants were assessed for potential acute side-effects before and throughout 46 hours after the dose. The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index (RI) of the anterior cerebral artery using duplex Doppler. Groups were comparable at the baseline. A bulging fontanelle occurred in the control and vitamin A groups, respectively, among 2.7% and 4.6% of the infants at 24 hours, and 2.4% and 4.5% of the infants at 48 hours. The groups did not differ in any other sign or symptom assessed. No infant developed intracranial haemorrhage. Mean RI values were normal and not different between groups at baseline or at 24 hours. Mean RI fell during the 24 hours, as normally occurs; the mean decrease was nearly identical in the two groups. A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI. The 52-μmol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants, but no increase in intracranial pressure. Acute side-effects following this intervention were rare and mild.

AB - A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-μmol (50000 IU) dose of vitamin A. Infants were assessed for potential acute side-effects before and throughout 46 hours after the dose. The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index (RI) of the anterior cerebral artery using duplex Doppler. Groups were comparable at the baseline. A bulging fontanelle occurred in the control and vitamin A groups, respectively, among 2.7% and 4.6% of the infants at 24 hours, and 2.4% and 4.5% of the infants at 48 hours. The groups did not differ in any other sign or symptom assessed. No infant developed intracranial haemorrhage. Mean RI values were normal and not different between groups at baseline or at 24 hours. Mean RI fell during the 24 hours, as normally occurs; the mean decrease was nearly identical in the two groups. A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI. The 52-μmol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants, but no increase in intracranial pressure. Acute side-effects following this intervention were rare and mild.

UR - http://www.scopus.com/inward/record.url?scp=0028670470&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0028670470&partnerID=8YFLogxK

M3 - Article

VL - 72

SP - 859

EP - 868

JO - Bulletin of the World Health Organization

JF - Bulletin of the World Health Organization

SN - 0042-9686

IS - 6

ER -