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## Complete Summary

#### GUIDELINE TITLE

Immunization of preterm and low birth weight infants.

#### BIBLIOGRAPHIC SOURCE(S)

Saari TN. Immunization of preterm and low birth weight infants.
Pediatrics 2003 Jul;112(1 Pt 1):193-8. \[45 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12837889)

#### 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)

Vaccine-preventable diseases:

-   Hepatitis B

-   Diphtheria

-   Tetanus

-   Pertussis

-   *Haemophilus influenzae* b infection

-   Poliomyelitis

-   Pneumococcal disease

-   Influenza

#### GUIDELINE CATEGORY

Prevention

#### CLINICAL SPECIALTY

Family Practice\
Pediatrics\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide updated information on the immunogenicity, durability, and
safety of routinely recommended childhood vaccines given to preterm and
low birth weight infants

#### TARGET POPULATION

Preterm and low birth weight infants

#### INTERVENTIONS AND PRACTICES CONSIDERED

Routine immunization using:

1.  Hepatitis B vaccine

2.  Diphtheria and tetanus toxoids with acellular pertussis (DTaP)
    vaccine

3.  Inactivated poliovirus (IPV) vaccine

4.  *Haemophilus influenzae* type b (Hib) vaccine

5.  Heptavalent pneumococcal conjugate vaccine (PCV7)

6.  Influenza vaccine

#### MAJOR OUTCOMES CONSIDERED

-   Seroconversion rates

-   Antibody concentrations

-   Vaccine-associated adverse events

### 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

**General**

*Timing*

Medically stable preterm (PT) and low birth weight (LBW) infants should
receive all routinely recommended childhood vaccines at the same
chronologic age as recommended for full-term (FT) infants. Under most
circumstances, gestational age at birth and birth weight should not be
limiting factors when deciding whether a PT or LBW infant is to be
immunized on schedule. Infants with birth weight less than 2,000 g,
however, may require modification of the timing of hepatitis B
immunoprophylaxis depending on maternal hepatitis B surface antigen
(HbsAg) status.

*Dosing*

Vaccine dosages normally given to FT infants should not be reduced or
divided when given to PT and LBW infants. Although studies have shown
decreased immune responses to some vaccines given to very low birth
weight (VLBW), extremely low birth weight (ELBW), and very early
gestational age (\<29 weeks) neonates, most PT infants produce
sufficient vaccine-induced immunity to prevent disease when full doses
are given. The severity of vaccine-preventable diseases in PT and LBW
infants precludes any delay in initiating the administration of these
vaccines.

*Vaccine Administration*

The anterolateral thigh is the site of choice when administering
intramuscular vaccines to PT infants. The choice of needle length used
for intramuscular vaccine administration is made on the basis of the
available muscle mass of the PT infant and may be less than the standard
7/8-inch to 1-inch length used for FT infants (Atkinson et al., 2002).

**Hepatitis B**

*Infants Born to HBsAg-Negative Mothers*

Medically stable PT infants and infants weighing greater than 2,000 g at
birth should be treated like FT infants and preferentially receive the
first dose of monovalent hepatitis B vaccine shortly after birth and no
later than hospital discharge. Practitioners who are certain of the
mother\'s negative HBsAg status and wish to use a hepatitis B-containing
combination vaccine for PT and LBW infants with birth weight greater
than 2,000 g must delay the first dose of the combination vaccine until
the infant is at least 6 weeks of age. There is no contraindication to
giving a birth dose of hepatitis B vaccine as the first of 4 doses when
a combination vaccine containing hepatitis B vaccine subsequently is
used. The final dose of hepatitis B vaccine should not be given earlier
than 6 months chronologic age.

Medically stable PT and LBW infants with birth weight less than 2,000 g
should receive the first dose of hepatitis B vaccine as early as 30 days
of chronologic age regardless of gestational age or birth weight.
Alternatively, PT and LBW infants weighing less than 2,000 g showing
consistent weight gain leading to discharge home from the hospital
before attaining 30 days of age should receive the first dose of
hepatitis B vaccine at the time of hospital discharge.

*Infants Born to HBsAg-Positive Mothers*

PT and LBW infants born to mothers who are HBsAg positive must receive
hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12
hours after birth, regardless of gestational age or birth weight.
Infants weighing less than 2,000 g and born to HBsAg-positive mothers
should not have the birth dose of hepatitis B vaccine counted as part of
the hepatitis B virus (HBV) immunization series, and 3 additional doses
of hepatitis B vaccine should be given starting at 1 month of age.
Combination vaccines containing a hepatitis B component have not been
assessed for efficacy when given to infants born to HBsAg-positive
mothers. All infants of HBsAg-positive mothers should be tested for the
presence of antibody to hepatitis B surface antigen (anti-HBs) and HBsAg
at 9 to 15 months of age, after completion of the HBV immunization
series. Some experts prefer to perform serologic testing 1 to 3 months
after completion of the primary series.

*Infants Born to Mothers Whose HBsAg Status Is Unknown*

All PT and LBW infants born to mothers whose HBsAg status is unknown at
the time of delivery should receive monovalent hepatitis B vaccine
within 12 hours of birth. Because infants weighing less than 2,000 g
have less predictable responses to hepatitis B vaccine given at birth,
they should be given hepatitis B immune globulin by 12 hours of life if
the mother\'s HBsAg status cannot be determined within that time period.
Hepatitis B immune globulin may be delayed up to 7 days for PT and LBW
infants weighing more than 2,000 g at birth while awaiting the mother\'s
HBsAg test results.

[Table
1](http://aappolicy.aappublications.org/cgi/content/full/pediatrics;112/1/193/T1)
in the original guideline provides a schematic outline for hepatitis B
immunoprophylaxis given to PT and LBW infants.

**Diphtheria and Tetanus Toxoid and Acellular Pertussis (DTaP),
*Haemophilus influenzae* Type b (Hib), and Inactivated Poliovirus (IPV)
Vaccines**

All medically stable PT and LBW infants should begin routine childhood
immunization with full doses of any DTaP, Hib, and IPV vaccines licensed
by the Food and Drug Administration at 2 months of chronologic age
regardless of gestational age or birth weight. Although apnea has not
been reported in ELBW infants born at less than 31 weeks\' gestation
after the use of DTaP vaccine alone, in conjunction with other routinely
recommended childhood vaccines, or in combination with other vaccine
antigens, it is deemed prudent to closely observe hospitalized ELBW
infants for significant adverse events for up to 72 hours after
immunization until such a time that sufficient data have been collected
to firmly establish a pattern of safety.

**Pneumococcal Conjugate Vaccine (PCV7)**

All PT and LBW infants are considered at increased risk of invasive
pneumococcal disease, and medically stable PT patients should receive
full doses of PCV7 beginning at 2 months of chronologic age.

**Influenza**

All PT infants are considered at high risk of complications of influenza
virus infection and should be offered influenza vaccine beginning at 6
months of age and as soon as possible before the beginning and during
influenza season. PT and LBW infants receiving influenza vaccine for the
first time will require 2 doses of vaccine administered 1 month apart.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=4251)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The conclusions in the guideline are based on current knowledge of the
immune response of preterm infants to specific antigens contained in
various vaccines. These data, however, are limited by the relatively
small number of preterm infants studied to date.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

**General Benefit**

-   Routine immunization of preterm (PT) and low birth weight (LBW)
    infants with vaccines universally given to full-term infants

-   Although the immunogenicity of some childhood vaccines may be
    decreased in the smallest PT infants, antibody concentrations
    achieved usually are protective.

**Specific Benefit**

-   Earlier initiation of hepatitis B virus (HBV) immunization provides
    timely protection of vulnerable PT infants who are more likely to
    receive multiple blood products and undergo surgical interventions.
    The theoretic risk of horizontal transmission from household members
    and other hospital visitors with chronic hepatitis B infection also
    would be minimized. Finally, hepatitis B vaccine given closer to the
    time of birth increases the likelihood that the hepatitis B vaccine
    series and other recommended childhood vaccines will be completed on
    time.

#### POTENTIAL HARMS

**Adverse Events**

In a study of 1,756 low birth weight (LBW) infants and 4,340 preterm
(PT) infants assessed for pneumococcal conjugate vaccine (PCV7)
immunogenicity, efficacy, and safety, the following results were
published: Most local and systemic adverse events from PCV7 were similar
in PT and full-term (FT) vaccine recipients. PT and LBW recipients of
PCV7 had more fever, emesis, irritability, and tenderness or swelling at
the injection site than did infants in a control group. Urticarial
reactions within 48 hours of PCV7 administration were more common in FT
and PT infants compared with controls. PT infants receiving PCV7
concomitantly with diphtheria and tetanus toxoids with whole-cell
pertussis (DTwP) and *Haemophilus influenzae* type b (Hib) vaccines
experienced more febrile seizures compared with FT infants, but this may
be reflective of the increased propensity for febrile convulsions of PT
infants, immunizations notwithstanding.

### 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)

Saari TN. Immunization of preterm and low birth weight infants.
Pediatrics 2003 Jul;112(1 Pt 1):193-8. \[45 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12837889)

#### 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 Infectious Diseases

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Committee on Infectious Diseases, 2002-2003*: Jon S. Abramson, MD,
*Chairperson*; Carol J. Baker, MD; Robert S. Baltimore, MD; Joseph A.
Bocchini, Jr, MD; Sarah S. Long, MD; Julia A. McMillan, MD; H. Cody
Meissner, MD; Keith R. Powell, MD; Charles G. Prober, MD; Margaret B.
Rennels, MD; Thomas N. Saari, MD; Leonard B. Weiner, MD

*Liaisons*: Jack Swanson, MD, AAP Practice Action Group; Joanne Embree,
MD, Canadian Paediatric Society; Marc A. Fischer, MD, Centers for
Disease Control and Prevention; Martin C. Mahoney, MD, American Academy
of Family Physicians; Mamodikoe Makhene, MD, National Institutes of
Health; Bruce G. Gellin, MD, MPH, National Vaccine Program Office;
Walter A. Orenstein, MD, Centers for Disease Control and Prevention;
Douglas R. Pratt, MD, Food and Drug Administration; Jeffrey R. Starke,
MD, American Thoracic Society

*Red Book Editor*: Larry K. Pickering, MD

*Consultant*: Edgar O. Ledbetter, MD

*Staff*: Martha Cook, MS

#### 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](http://aappolicy.aappublications.org/cgi/content/full/pediatrics;112/1/193).

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 20, 2004. The
information was verified by the guideline developer on May 27, 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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Date Modified: 11/3/2008