TB Manual

The literature on this subject is very limited and most of the evidence comes from a handful of retrospective studies of small cohorts of pregnant women.^116–123 There has been one systematic review and meta-analysis that has examined the pregnancy outcomes of TB patients, both maternal and neonatal, and the results show a significant association with poorer outcomes in both the mother and fetus/newborn compared to their TB-unaffected counterparts.¹²⁴ The majority of congenital TB cases reported in the literature occurred between the time Bietzke published the initial proposed diagnostic criteria in 1935 (see the following section) and prior to the introduction of INH in the 1950s.¹²⁵

In 2 different literature reviews, congenital TB occurred more frequently in women diagnosed with miliary, meningeal or genitourinary TB.^126,127 This is likely due to the route of transmission, either hematogenously through the umbilical cord or aspiration of infected fluids at the time of delivery.^23,128,129 In one review, almost three quarters of women were diagnosed with TB postpartum.¹³⁰ In both reviews, ≥50% of women were diagnosed with TB after their infant was diagnosed with congenital TB.^131,125

The initial criteria for diagnosis of congenital TB were outlined by Bietzke in 1935 and updated by Cantwell in 1994.^126,127 Historically, to fulfill the diagnostic criteria for congenital TB, the infant must have “tuberculous lesions and at least one of the following: (1) lesions in the first week of life; (2) a primary hepatic complex or caseating hepatic granulomas; (3) tuberculous infection of the placenta or the maternal genital tract; or (4) exclusion of the possibility of postnatal transmission by a thorough investigation of contacts”¹²⁸

However, many children who have congenital TB do not fulfill these criteria based on more recent literature reviews. The clinical features reported are nonspecific and overlap with neonatal sepsis. The most common symptoms reported include respiratory distress, fever, hepatomegaly (and/or splenomegaly), poor feeding, lethargy, irritability, lymphadenopathy, abdominal distension, ear discharge, pustular skin lesions and cyanosis.^118,129,130 The median age of presentation of congenital TB is between 2 to 4 weeks of life.^117,126

Management of the newborn (adapted with permission):¹³²

1. Maternal TB disease associated with hematogenous spread or genitourinary TB disease:

   • Send placenta for histopathology, AFB microscopy, culture and PCR.

   • Ensure mother has up-to-date HIV test (including third trimester).

   • Perform TST on newborn (note: a negative TST in a newborn does not rule out TB infection or disease).

   • Conduct physical exam of the newborn for signs and symptoms of congenital TB.

   • Carry out diagnostic investigations: chest x-ray, abdominal ultrasound, lumbar puncture for AFB microscopy and culture and PCR, gastric aspirates for AFB microscopy and culture.

   • Start empiric TB treatment immediately if any of the above are concerning for TB disease.

   • If no clinical or diagnostic evidence of TB disease then at a minimum prescribe preventive therapy with either isoniazid or rifampin if the source case is known to have drug-susceptible TB; if the drug susceptibilities are not yet known, then both isoniazid and rifampin preventive therapy should be considered.

   • Schedule follow-up appointment between 2 to 4 weeks of age with repeat CXR; continue routine follow-up until 6 months old.

   • If isoniazid is used as preventive therapy, then repeat TST at 6 months old; if negative it can be discontinued, if positive continue, repeat at 9 months.

2. Maternal pulmonary TB considered infectious by her treating physicians:

   • Send placenta for histopathology, AFB microscopy, culture and PCR.

   • Ensure mother has up-to-date HIV test (including third trimester).

   • Perform physical exam of the infant for signs and symptoms of congenital TB.

   • Consider more limited diagnostic evaluation: chest x-ray, abdominal ultrasound.

   • Perform TST on infant (note: a negative TST in a newborn does not rule out TB infection or disease).

   • Start preventive therapy if no evidence of congenital TB (same drug strategy as scenario 1).

   • Schedule follow-up at 4 weeks old with repeat CXR, with routine follow-up until 6 months old.

   • If isoniazid is used as preventive therapy, then repeat TST at 6 months old; if negative it can be discontinued, if positive, repeat at 9 months.

3. Maternal pulmonary TB considered noninfectious by her treating physicians:

   • Send placenta for histopathology, AFB microscopy, culture and PCR.

   • Ensure mother has up-to-date HIV test (including third trimester).

   • Conduct physical exam of the infant for signs and symptoms of congenital TB.

   • No routine diagnostic testing is necessary in healthy infant.

   • Schedule routine follow-up until 6 months old.

4. Mother completed TB treatment prior to pregnancy:

   • No specific actions required.

5. Household family member treated for TB:

   • If the family member is still infectious, there should be no household contact with the infant until they are deemed noninfectious.

   • If the family member is noninfectious and adherent to treatment, no specific action is required.

6. Neonate diagnosed with congenital TB:

   • The mother should be immediately investigated for TB disease, appropriate to the site of suspected disease.

   • Strong consideration should also be given to investigating other caregivers if the mother’s evaluation is negative and the onset of symptoms is compatible with postnatal acquisition.

   • These infants usually have large bacterial burdens: if they are intubated or have aerosol-generating procedures, then airborne precautions should be followed.

If the infant is diagnosed with congenital or neonatal TB disease, the same treatment regimens are used as in older children (as noted previously). In the absence of positive culture results from the infant, the treatment regimen chosen should be guided by source case’s mycobacterial culture susceptibility results.

Separation of the infant and mother is recommended only if the mother is very ill, is still considered infectious or is suspected/confirmed of having drug-resistant TB. If these have been excluded, or the infant has been started on effective therapy for TB infection or disease, then it is safe for the infant to room in with the mother and breastfeed while the mother is on effective TB therapy. Discharge of the mother and infant should only occur if all other household members have been evaluated for TB disease and are on appropriate therapy.

In those children who qualify for the BCG vaccine, based on provincial or territorial guidelines, it should not be given to infants who: (1) are treated for suspected TB disease; (2) have a positive TST; (3) are on TB preventive therapy; or (4) are born to a mother with HIV (until HIV transmission has been ruled out). For those infants treated for perinatal TB infection or disease and who qualify for BCG, their BCG dose can be administered after the appropriate duration of treatment for infection or disease is completed.

Good practice statement

• Investigation for congenital TB should be considered in a neonate born to a mother with epidemiologic risk factors for TB and who has features of sepsis, non-resolving pneumonia or failure to thrive.

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