Comprehensive follow-up care and life-threatening illnesses among high-risk infants: A randomized controlled trial.

CONTEXT: Inner-city high-risk infants often receive limited and fragmented care, a problem that may increase serious illness. OBJECTIVE: To assess whether access to comprehensive care in a follow-up clinic is cost-effective in reducing life-threatening illnesses among high-risk, inner-city infants. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: A total of 887 very-low-birth-weight infants born in a Texas county hospital between January 1988 and March 1996 and followed up in a children's hospital clinic. One hundred four infants who became ineligible or died after randomization but before nursery discharge were excluded from the analysis. INTERVENTIONS: Infants were randomly assigned to receive routine follow-up care (well-baby care and care for chronic illnesses; n = 441) or comprehensive care (which included the components of routine care plus care for acute illnesses, with 24-hour access to a primary caregiver; n = 446). MAIN OUTCOME MEASURES: Life-threatening illnesses (ie, causing death or hospital admission for pediatric intensive care) occurring between nursery discharge and age 1 year, assessed by blinded evaluators from inpatient charts and state Medicaid and vital statistics records; and hospital costs (estimated from department-specific cost-to-charge ratios). RESULTS: Comprehensive care resulted in a mean of 3.1 more clinic visits and 6.7 more telephone conversations with clinic staff (P<.001 for both). One-year outcomes were unknown for fewer comprehensive-care infants than routine-care infants (9 vs 28; P =.001). Identified deaths were similar (11 in comprehensive care vs 13 in routine care; P =.68). The comprehensive-care group had 48% fewer life-threatening illnesses (33 vs 63; P<.001), 57% fewer intensive care admissions (23 vs 53; P =.003), and 42% fewer intensive care days (254 vs 440; P =.003). Comprehensive care did not increase the mean estimated cost per infant for all care ($6265 with comprehensive care and $9913 with routine care). CONCLUSION: Comprehensive follow-up care by experienced caregivers can be highly effective in reducing life-threatening illness without increasing costs among high-risk inner-city infants. JAMA. 2000;284:2070-2076.

Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk.

OBJECTIVE: The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. STUDY DESIGN: This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. RESULTS: Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. CONCLUSIONS: The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted.

Have Medicaid reimbursements been a credible measure of the cost of pediatric care?

OBJECTIVE: Despite uncertain validity as a measure of cost, Medicaid reimbursements may be used to compare the costs of different pediatric interventions. We explored the credibility of Medicaid reimbursements as a measure of the costs of inpatient care associated with two different approaches to follow-up care for high-risk indigent infants. DESIGN: Analysis of Medicaid reimbursements within a randomized trial of primary follow-up care. PATIENTS: Infants

Emergency room visits despite the availability of primary care: a study of high risk inner city infants.

Very low birth weight preterm infants randomized to receive comprehensive primary care in an ongoing clinical trial were prospectively evaluated to determine the cause of frequent emergency room use despite the availability of a primary healthcare provider and specific social services. Mothers were interviewed to assess knowledge of available resources, when to seek medical attention, and the perception of problems that limit access to health care. The healthcare provider was not called before 49% of the emergency room visits and mothers often did not recall what infant signs needed medical attention. Seventy-nine percent of emergency room visits were delayed more than 10 hours; and 15 of 62 (24%) emergency room visits resulted in admittance to the hospital. We conclude that in high-risk populations, the mere availability of primary care does not assure that it will be used. New strategies to help parents know when and how to use services are needed to increase the delivery of primary care.

Results at age 8 years of early intervention for low-birth-weight premature infants. The Infant Health and Development Program.

OBJECTIVE: To reevaluate at age 8 years children who had participated during the first 3 years of life in a randomized clinical trial of special services for low-birthweight (LBW) premature infants. DESIGN: Follow-up of a randomized controlled trial of premature infants (< or = 37 weeks' gestation), stratified by 2 LBW groups (lighter [< or = 2000 g] and heavier [2001-2500 g]) and divided into intervention (n=377) and follow-up only (n=608) groups. SETTING: Eight sites serving diverse populations. PARTICIPANTS: At age 8 years, 874 children were assessed: 336 in the intervention group and 538 in the follow-up only group. INTERVENTION: The 3-year intervention consisted of home visits (birth to 3 years), child development center services (ages 1 to 3 years), and parent group meetings (ages 1 to 3 years). PRIMARY OUTCOME MEASURES: Cognitive functioning (Weschler Intelligence Scale for Children-III; Peabody Picture Vocabulary Test-Revised); academic achievement (Woodcock-Johnson Tests of Achievement-Revised); and parental reports of school performance, behavior (Child Behavior Checklist), and health (Child General Health Survey). RESULTS: At age 8 years, in the entire cohort and in the lighter LBW stratum, the intervention and follow-up only groups were similar on all primary outcome measures. Differences favoring the intervention group were found within the heavier LBW group: full-scale IQ score (4.4 points higher, P=.007), verbal IQ score (4.2 points higher, P=.01), performance IQ score (3.9 points higher, P=.02), mathematics achievement score (4.8 points higher, P=.04), and receptive vocabulary score (6.7 points higher, P=.001). On a physical functioning subscale, the whole intervention group received less favorable ratings, while the lighter LBW intervention group had lower maternal ratings assessing social limitations caused by behavior. CONCLUSION: Although at age 8 years there were modest intervention-related differences in the cognitive and academic skills of heavier LBW premature children, attenuation of the large favorable effects seen at 3 years was observed in both the heavier and lighter LBW groups. This indicates a need to develop additional intervention strategies for LBW premature children that can provide sustained benefits.

Neonatal neurologic characteristics of preterm twin infants <1,250 gm birth weight.

The study objectives were to determine the incidence, time of onset, and clinical characteristics of neonatal neurologic injury in preterm twin infants <1,250 gm birth weight. Forty-one twin infants of birth weight 929 gm +/- 160 and 27.3 +/- 1.96 weeks gestation were evaluated and compared to 225 singleton infants <1,250 gm. Seventeen infants were monozygotic and 24 dizygotic. Six of the 9 monozygotic pregnancies were complicated by the polyhydramnios/oligohydramnios syndrome; a weight discordancy of >20% was observed in 8 of the monozygotic twin sets and polycythemia (hematocrit >65%) in 3 infants. Nine (22%) of the 41 infants died. Periventricular-intraventricular hemorrhage (PV-IVH) developed in 11 (27%) of 41 infants and was severe in 9 (22%) infants. IVH was noted on day 1 (n = 2), day 2 (n = 3), and day 3 (n = 6). IVH developed in 69 (30%) of the 225 singletons and was severe in 28 (12%) infants. Twin infants were more likely to have been delivered via cesarean section, to have required intubation in the delivery room, and to have been administered surfactant as compared with singletons (P < .01). It was concluded that preterm twin infants <1,250 gm are at high risk for developing severe IVH, and that the onset of IVH was within the first 3 postnatal days in all cases.

Bilateral cystic periventricular leukomalacia in the premature infant: associated risk factors.

BACKGROUND: Bilateral cystic periventricular leukomalacia (PVL) is a major cause of neurodevelopmental delay in the premature infant. Thus, early identification of the preterm infant at highest risk for the subsequent development of this lesion is critical. OBJECTIVES: The three objectives of this case-control study were: (1) to determine the basic characteristics of cystic PVL, (2) to assess the relationship of perinatal clinical events and PVL, and (3) to ascertain the feasibility of identifying early those preterm infants at highest risk for the development of PVL. METHODS: The medical records and cranial ultrasound scans (HUSs) were reviewed for 632 infants weighing less than 1750 g who were admitted to the neonatal intensive care unit between January 1992 and December 1993. PVL developed in 14 infants of 1285 +/- 301 g birth weight (BW) and 29.4 +/- 1.5 weeks' gestational age (GA); severe intraventricular hemorrhage (n = 21) and intraparenchymal echodensity (n = 12) developed in 33 infants of 904 +/- 248 g BW and 26.6 +/- 1.8 weeks' GA; and 585 infants of 1315 +/- 324 g BW and 29.7 +/- 2.4 weeks' GA with normal HUS findings (n = 473) or grade I or II intraventricular hemorrhage (n = 112) served as a comparison group. RESULTS: Cystic PVL was observed in 14 (2.3%) of 632 infants weighing less than 1750 g, more specifically, in 3.2% of infants weighing less than 1500 g. Cysts were noted from the 7th to 14th days of life in 10 infants and from the 20th to 46th days of life in 4 infants. Ten (70%) of the infants had relatively benign clinical courses, and most cases were detected by routine HUS surveillance. Over hypotension in the immediate perinatal period was noted in 3 (21%) infants; late hypotension developed in 1 additional infant. Univariate analysis indicate that two clinical indicators, prolonged rupture of membranes (PROM) and chorioamnionitis, were significant predictors of PVL. For PROM, the odds ratio estimate and the 95% confidence limit are 6.59 and 1.96 to 22.10, with a sensitivity of 28.6% and positive predictive value of 11.5%. Similar values for chorioamnionitis are 6.77 (1.77 to 25.93), with a sensitivity of 21.4% and positive predictive value of 11.5%. CONCLUSIONS: (1) Most cases of symmetric cystic PVL occurred in infants with relatively benign clinical courses and were only detected by routine ultrasound screening. (2) Postnatal systemic hypotension seems to be an uncommon associated event. (3) Preterm infants born to mothers with PROM and/or chorioamnionitis seem to be at an increased risk for the development of PVL and should be carefully evaluated.