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Biomedical subjects

K H Fendt

Publications and source records attributed to K H Fendt.

2 recordsLinked to original sources

Infant Health and Development Program for low birth weight, premature infants: program elements, family participation, and child intelligence.

The Infant Health and Development Program was an eight-site randomized controlled trial testing the efficacy of early intervention to enhance the cognitive, behavioral, and health status of low birth weight, premature infants. The 377 intervention families received for the first 3 years of life: (1) pediatric follow-up, (2) home visits, (3) parent support groups, and (4) a systematic educational program provided in specialized child development centers. The control group (n = 608) received the same pediatric follow-up and referral services only. This paper describes the delivery of the intervention and its outcomes. A Family Participation Index that was the sum of participation frequencies in each of the program modalities unique to the intervention revealed that program implementation was not different across the eight sites. Index scores did not vary systematically with mother's ethnicity, age, or education or with child's birth weight, gender, or neonatal health status; but they were positively related to children's IQ scores at age 3. Only 1.9% of children of families in the highest tercile of participation scored in the mentally retarded range (IQ less than or equal to 70), whereas 3.5% and 13% of children in the middle and lowest participation terciles, respectively, scored in the retarded range. Similar findings were obtained for borderline intellectual functioning. These findings are consistent with previous research linking intensity of intervention services with degree of positive cognitive outcomes for high-risk infants. The determinants of variations in individual family participation remain unknown.

Child Day Care Centers↗

Random assignment in clinical trials: issues in planning (Infant Health and Development Program).

Various options available for the randomization of subjects into groups in a clinical trial are discussed, emphasizing the issues of logistics given less focus in more mathematical treatments. We discuss advantages and disadvantages of total randomization, of Zelen-type randomization procedures, of Efron-type procedures vs more classical blocking procedures to control the balance between groups, and of Simon-Pocock-type procedures vs more classical stratification for controlling possible biases in prognostic factors. Finally, we discuss issues related to choice and implementation of randomization procedures. The discussion is illustrated with the processes of decision-making in a national collaborative randomized clinical trial, the Infant Health and Development Program.

Bias↗