Infant clinical considerations - PowerPoint Presentation

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Infant clinical considerations

IMPAACT 2010 study-specific TrainingMay 2017

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Overview

Medical, Medication, and Feeding HistoriesPhysical Examinations

Laboratory Evaluations

Source Documentation and eCRF Requirements

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Overall Approach to Infant Management

Infants enrolled in this study should receive ARV prophylaxis and other standard interventions such as cotrimoxazole, isoniazid preventive therapy, and childhood immunizations consistent with local standards of care from non-study sources. Likewise, infants diagnosed with HIV infection should receive ART consistent with local standards of care from non-study sources.

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Overall Approach to Infant Management

In the event that mothers need to interrupt ART (e.g., due to an adverse event), information and counseling will be provided regarding locally-available options for reducing the risk of perinatal HIV transmission. Such options may include infant ARV prophylaxis during breastfeeding and replacement feeding if determined to be safe and accessible and if the mother’s ART interruption is likely to be prolonged.

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Infant Medical and Medication History

Required at each scheduled visitBaseline history at Delivery Visit

Interval (since the last visit) histories at subsequent visits

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Infant Medical and Medication History

Birth details should ideally be obtained from medical recordsThereafter, history information may be obtained based on maternal report but available medical records should also be obtained when possible to supplement maternal report

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Infant Baseline History

Assess for and

Source Document

Enter into eCRFs

Date and time of birth

Yes

Sex, estimated gestational age, length, weight, and head circumference at birth

Yes

Apgar scores at 1 and 5 minutes

Yes

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Infant Baseline History

Assess for and

Source Document

Enter into eCRFs

Congenital anomalies and other medical conditions (signs, symptoms, illnesses, other diagnoses) identified between birth and the Delivery Visit

Any conditions

(adverse events)

that meet criteria in protocol Section 7.2

including all suspected

congenital anomalies

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Infant Baseline History

Assess for and

Source Document

Enter into eCRFs

Medications taken between birth and the Delivery Visit

All ARVs

Any use of:

Cotrimoxazole

Isoniazid prophylaxis

Medications to treat active TB

All medications taken at onset of or in response to adverse events that are specified to be entered into eCRFs per Section 7.2

Note: eCRFs will also capture whether traditional medications were taken during follow-up.

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Infant Interval History

Assess for and

Source Document

Enter into eCRFs

Current status of conditions that were ongoing at the

previous visit

Any updates of

previous entries

(e.g., resolution dates)

Occurrence of any new conditions (signs, symptoms, illnesses, and other diagnoses) since the last visit

Any newly identified adverse events

that meet criteria in protocol Section 7.2

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Infant Interval History

Assess for and

Source Document

Enter into eCRFs

Current status of medications that were ongoing at the last visit

Any updates of

previous entries

(e.g.,

stop dates)

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Infant Interval History

Assess for and

Source Document

Enter into eCRFs

Use of any new medications

since

the last visit

All ARVs

Any use of:

Cotrimoxazole

Isoniazid prophylaxis

Medications to treat active TB

All medications taken at onset of or in response to adverse events that are specified to be entered into eCRFs per Section 7.2

Note: eCRFs will also capture whether traditional medications were taken during follow-up.

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Infant Feeding History

Required at each scheduled visitAt Delivery Visit: feeding history since birth

At subsequent scheduled visits: interval

(since the last visit) feeding history

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Infant Feeding History

At this visit, was the infant's feeding method assessed?

Since the last visit, has there been a change in the infant's feeding method?

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QLW10010: Infant Feeding Method

QLW10011: Breastfeeding, Formula, & Complementary Food Record

Has infant been breastfed?

Breastfed by mother or someone else?

Date and time of first breastfeeding

Date of last exposure to breast milk

Has infant been formula fed?

Date of first formula feeding

Has infant received complementary foods?

Date of first complementary food

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Covered on Day 2 of training as part of Delivery Visit session

Complete Infant

Physical Exam

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LengthWeight

Head circumference Fontanel closure

Examination of body systems driven by prior and new signs, symptoms, and diagnoses

At all visits, additional assessments may be performed

at the discretion of the examining clinician

Targeted Infant

Physical Exam

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InfantGrowth Monitoring

At all visits:

Current measurements should be charted and compared to measurements recorded at the last visit to assess for appropriate increases

Weight-for-length should be assessed in relation to WHO growth standards

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DAIDS Grading Table

Version 2.1

should be

weight-for-length z score

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InfantLaboratory Evaluations

Complete blood count, ALT, creatinine

Delivery Visit for all infants

[Week 26 Visit if currently breastfeeding]

Additionally if clinically indicated

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Recording Test Results on Laboratory eCRFs

All creatinine results

All Grade 2 or higher ALT results

All grade 3 or higher hemoglobin, WBC, ANC, and platelet count results

All results that are serious as defined in the DAIDS EAE Manual

*Regardless of whether test was protocol-specified or ordered for clinical purposes

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Infant Evaluations

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Recording onAdverse Event eCRFs

All Grade 3 or higher adverse events

All suspected congenital anomalies

All SAEs as defined in the DAIDS EAE Manual

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Some examples

Event

Enter Value

in Lab eCRF?

Enter Adverse Event eCRF?

Grade 1 hemoglobin

No

No

Grade 2 hemoglobin

No

No

Grade 3 hemoglobin

Yes

Yes*

Grade 4 hemoglobin

Yes

Yes*

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Some examples

Event

Enter Value

in Lab eCRF?

Enter Adverse Event eCRF?

Grade 1 hemoglobin

No

No

Grade 2 hemoglobin

No

No

Grade 3 hemoglobin

Yes

Yes*

Grade 4 hemoglobin

Yes

Yes*

*AE term = decreased hemoglobin

or anemia if symptomatic

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Adverse Event Management

All adverse events must be source documented in participant research records, including the severity of each event and its relationship to study drug (infant exposure in utero or through breastfeeding)

All adverse events must be followed to resolution (return to baseline) or stabilization, with the frequency of repeat evaluations determined by the clinical significance of each event

Grade 3 or higher laboratory tests should be repeated as soon as possible (within 3 business days) and all grade 3 or higher adverse events should be re-evaluated at least weekly until improvement to grade 2 or lower

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Adverse Event Management

Infant adverse events will be managed consistent with the best medical judgment of the site investigator and local clinical practice standards It is not expected that maternal study drug regimens will routinely be modified in response to infant adverse events; site investigators may modify use of infant ARVs and other concomitant medications in response to infant adverse events

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Adverse Event Management

Consultation with the CMC is available but not required for most infant adverse eventsShould an infant experience a grade 3 or higher adverse event assessed as related the mother’s current study drug regimen, the CMC should be consulted

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InfantLaboratory Evaluations

HIV Nucleic Acid Test (NAT)

Delivery, Week 6, and Week 14 Visits for all infants

[Week 26 and Week 38 Visits if any exposure to breast milk since the last NAT]

Week 50 Visit for all infants

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Infant HIV Infection

Any infant with a positive HIV NAT result should be recalled for confirmatory testing as soon as possible and within 28 days of specimen collection for the initial test

3 mL of blood should be collected for the testing and residual plasma should be stored

If the second test does not confirm the initial result, the CMC should be consulted for guidance on next steps to clarify the infant’s HIV status

Pending confirmatory testing, infant prophylaxis should be managed consistent with local standards of care

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Infant HIV Infection

All infants identified with HIV infection will remain in study follow-up but will be referred to non-study sources of HIV care and treatment as soon as possible

Study visits will be conducted as originally scheduled with the exception that no further HIV tests will be performed and stored plasma will be used for antiretroviral resistance testing

Study sites may perform additional laboratory testing as needed to facilitate rapid initiation of ART for infected infants

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What are your questions?

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