Objective 2: Recruitment and screening

Recruitment

Children ranging from newborn (10-14 days old) to 4 years, 5 months of age are being recruited across two sites (Boston and St. Louis).

1) Newborns are recruited on-site at hospital maternity wards and from associated well-baby clinics - neonates recruited for study must be between 37 weeks 4 days and 41 weeks 3 days at birth.

2) Children between 3 months and 4 years, 5 months are recruited from satellite physician offices affiliated with the institution sites and/or the hospital maternity wards.

3) Subjects are also recruited from community centers as well as the general metropolitan area associated with each study site through lists provided by the marketing agency.

Screening procedures

1) During recruitment, staff introduced the study (during medical visits and/or by telephone).

2) If the parents wished to participate, informed consents were signed, and appointments were made for onsite evaluation and MR scanning after passing the screening procedures.

3) Screening was conducted in person or by telephone. The Full Telephone Screening Interview, Family History Interview for Genetic Studies (FIGS), and the neurological exam were given.

4) For newborns, parents of potentially eligible infants were approached as soon after delivery as appropriate, and the study was explained to them. Children recruited as newborns received the first time-point evaluation (neurobehavioral, neurological, and MRI examination) 10 – 14 days after the expected date of confinement (EDC or due date). Consent was obtained and the evaluation and MR study was scheduled no sooner than 10 days after birth, a time when initial physiologic post-delivery adjustment had been accomplished for most infants.

On-site procedures

All evaluations were conducted on site. The evaluation and MR study might have taken more than one appointment day, depending upon the preference of the parents and the temperament and fatigue of the child.

1) Prior to each scheduled visit, the project coordinator called the family of the recruited child to ensure that the child was in good health. The parents were asked whether the child had acquired an illness such as a cold or gastrointestinal disturbance.

2) A physician conducted the physical/neurological examination. A psychologist or trained research assistant conducted testing with a battery of neuropsychological tests. Results of these tests will be used for purposes of brain-behavior correlations and also to determine continuance in the study. Refer to Table 17 on page 46 for a list of Objective 2 procedures.

MR procedures

The average scanning time for anatomical MRI, DTI, relaxometry and MRS is approximately 40-60 minutes. For children who do not remain comfortable and cooperative the study may be terminated early.

The entire procedure from arriving to the MR suite to leaving the suite upon completion of the MR studies should take approximately 1 to 1-1/2 hours (2-2.5 hours for newborns and young infants).

1) Children who do not fall asleep or who express anxiety about the MR procedures may be brought back for the scan at a different session.

2) Families will be asked to return for follow-up evaluations and MR scans at intervals that vary depending upon the age at which the child enters the study.

The following procedures are used to monitor the children while they are in the scanner:

· Pulse oximetry (subjects <3 months)

· Visual inspection by a skilled attendant

This skilled attendant is trained and knowledgeable in

a) rapidly removing the infant from the bore should that be needed, and

b) neonatal/child CPR and resuscitation.

For more information, please see the NIHPD Protocol.