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Complete Summary

GUIDELINE TITLE

Controversies concerning vitamin K and the newborn.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

American Academy of Pediatrics (AAP) Policies are reviewed every 3 years by the authoring body, at which time a recommendation is made that the policy be retired, revised, or reaffirmed without change. Until the Board of Directors approves a revision or reaffirmation, or retires a statement, the current policy remains in effect.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

  • Early vitamin K deficiency bleeding (formerly known as classic hemorrhagic disease of the newborn)
  • Late vitamin K deficiency bleeding

GUIDELINE CATEGORY

Prevention

CLINICAL SPECIALTY

Family Practice
Pediatrics
Preventive Medicine

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

To present updated recommendations for the use of vitamin K in the prevention of early and late vitamin K deficiency bleeding

TARGET POPULATION

All newborns, particularly newborns who are breastfed exclusively

INTERVENTIONS AND PRACTICES CONSIDERED

Intramuscular vitamin K1 administration

MAJOR OUTCOMES CONSIDERED

  • Rate of late vitamin K deficiency bleeding
  • Relationship between newborn parenteral administration of vitamin K and incidence of childhood cancer

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

METHODS USED TO ANALYZE THE EVIDENCE

Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Because parenteral vitamin K has been shown to prevent vitamin K deficiency bleeding (VKDB) of the newborn and young infant and the risks of cancer have been unproven, the American Academy of Pediatrics recommends the following:

  1. Vitamin K1 should be given to all newborns as a single, intramuscular dose of 0.5 to 1 mg (American Academy of Pediatrics, American College of Obstetricians and Gynecologists, 1992).
  2. Additional research should be conducted on the efficacy, safety, and bioavailability of oral formulations and optimal dosing regimens of vitamin K to prevent late vitamin K deficiency bleeding.
  3. Health care professionals should promote awareness among families of the risks of late vitamin K deficiency bleeding associated with inadequate vitamin K prophylaxis from current oral dosage regimens, particularly for newborns who are breastfed exclusively.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting each recommendation is not specifically stated.

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Appropriate use of vitamin K in the prevention of early and late vitamin K deficiency bleeding

POTENTIAL HARMS

Some earlier studies attempted to show an association between intramuscular vitamin K administration and increased incidence of childhood cancer, but more recent studies failed to substantiate this concern.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Staying Healthy

IOM DOMAIN

Effectiveness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2003 Jul

GUIDELINE DEVELOPER(S)

American Academy of Pediatrics - Medical Specialty Society

SOURCE(S) OF FUNDING

American Academy of Pediatrics

GUIDELINE COMMITTEE

Committee on Fetus and Newborn

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee on Fetus and Newborn, 2002-2003: Lillian Blackmon, MD, Chairperson; Daniel G. Batton, MD; Edward F. Bell, MD; William A. Engle, MD; William P. Kanto, Jr, MD; Gilbert I. Martin, MD; Warren Rosenfeld, MD; Ann R. Stark, MD

*Carol A. Miller, MD Past Committee Member

Liaisons: Keith J. Barrington, MD, Canadian Paediatric Society; Tonse Raju, MD, DCH, National Institutes of Health; Laura E. Riley, MD, American College of Obstetricians and Gynecologists; Kay M. Tomashek, MD, Centers for Disease Control and Prevention; Carol Wallman, MSN, RNC, NNP, National Association of Neonatal Nurses

Staff: Jim Couto, MA

*Lead author

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

American Academy of Pediatrics (AAP) Policies are reviewed every 3 years by the authoring body, at which time a recommendation is made that the policy be retired, revised, or reaffirmed without change. Until the Board of Directors approves a revision or reaffirmation, or retires a statement, the current policy remains in effect.

GUIDELINE AVAILABILITY

Electronic copies: Available from the American Academy of Pediatrics (AAP) Web site.

Print copies: Available from American Academy of Pediatrics, 141 Northwest Point Blvd., P.O. Box 927, Elk Grove Village, IL 60009-0927.

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on February 19, 2004. The information was verified by the guideline developer on March 29, 2004.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please contact the Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest Point Blvd, Elk Grove Village, IL 60007.

DISCLAIMER

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