Search PubMed⌕ Search

Biomedical subjects

M J Maisels

Publications and source records attributed to M J Maisels.

At least 19 recordsLinked to original sources

Less aggressive treatment of neonatal jaundice and reports of kernicterus: lessons about practice guidelines.

The publication of guidelines calling for less aggressive treatment of jaundice in newborns has been followed by a reappearance of case reports of kernicterus. These case reports illustrate important issues for writers and consumers of practice guidelines. One issue is the particular salience of identified patients with bad outcomes, and their potentially disproportionate influence on decision-makers. A second issue is whether, when good evidence of treatment benefit is lacking, policymakers should recommend what has traditionally been done, recommend less treatment, or not make recommendations at all. Finally, the cases raise the question of whether treatment guidelines should be more conservative than their authors actually believe is necessary, to take into account the likelihood that they will not be closely followed. We believe that case reports can serve as an important early warning system, but policymakers should be aware of their potentially disproportionate influence. In the long run, patients and clinicians will be best served by guidelines that summarize and acknowledge the limitations of existing evidence, that allow a wide range of treatment options when evidence is weak, and that recommend what the guideline authors actually believe should be done. In the short run a period of readjustment may be required, however, as clinicians become accustomed to guidelines written to be followed, rather than bent.

Evidence-Based Medicine↗

Bilirubin levels and severe retinopathy of prematurity in infants with estimated gestational ages of 23 to 26 weeks.

Oxidative injury may contribute to the development of retinopathy of prematurity (ROP), and bilirubin may be a physiologically important antioxidant. Therefore we evaluated the relationship of ROP to bilirubin levels in 157 infants born at 23 to 26 weeks estimated gestational age. We found no definite association between bilirubin levels and severe ROP.

Analysis of Variance↗

Capillary refill time in the hands and feet of normal newborn infants.

We measured capillary refill time (CRT) in a convenience sample of 137 healthy newborns between 1 and 120 hours of age and 36-42 weeks gestation in the well-baby nursery of a large community hospital. CRT was measured by applying moderate pressure to the dorsum of the right hand and right foot for 5 seconds. Pressure was released and the time for complete refilling of the blanched area noted. Each infant was studied only once. We also measured ambient temperature and the skin temperature of the dorsum of the hand and foot and tested interobserver agreement. Mean CRT was 4.23 +/- 1.47 s (SD) range 1.63-8.78 s) in the hand and 4.64 +/- 1.41 s (range 2.15-9.94 s) in the foot (p = 0.0001) and did not change significantly in the first 72 hours. CRT decreased with increasing temperature. Environmental temperature, axillary temperature, and temperature of the hand and foot were all significantly and indirectly related to CRT, the strongest relationship existing between CRT and the skin temperature of the hand (r = -0.59, 95% CI -0.69, -0.47 p < 0.00001) and foot (r = -0.33, 95% CI -0.46, -0.16 p < 0.0001). With triplicate measurements, there was a statistically significant, but clinically moderate, order effect, CRT decreasing with each successive measurement (p < 0.0001). Interobserver agreement was fair, the correlation coefficient (r) ranged from 0.47 to 0.71. We conclude that CRT as measured in the hand or foot of a newborn infant in the first 5 days of life is a relatively subjective measurement with an endpoint that is not easy to define and a wide range of values in normal infants. It is influenced significantly by environmental, axillary, and skin temperatures. Since there is no accepted standard for measuring decreased perfusion in the newborn, it is impossible to document the clinical utility of CRT in this population. Further studies are necessary before CRT can be accepted as a useful measure of peripheral perfusion and circulatory status in the newborn infant.

Blood Circulation↗

Changing partners: the dance of infant formula changes.

The purpose of the study was to establish the frequency of, reasons for, and outcome of formula changes in infants. In this survey, we interviewed a convenience sample of 100 parents in our pediatric outpatient clinic and 75 parents in private pediatric office practices regarding their baby's initial formula, changes in formula, age at change, reason for change, initiator of the change, and outcome. The infants were 30-210 days old. Sixteen of the 175 infants (9%) were started on nonstandard formulas at birth. Fifty-eight of the remaining 159 infants (36%) were changed from regular to nonstandard formulas. After using nonstandard formulas, only seven infants (4%) were ever challenged subsequently with regular formula and all did well. Colic and regurgitation were the main reasons for switching formulas. In 47% the decision to change the formula was made by the mother and in 44% by the pediatrician. Following the formula change, mothers reported improvement or complete resolution of symptoms in 80% of infants. Although published estimates of formula intolerance range from 2% to 7.5%, one in three infants experiences a formula change, suggesting that nonstandard formulas are used excessively by both mothers and physicians. Nevertheless, in the vast majority of cases, parents report that the changes result in improvement or resolution of symptoms. Thus, while this practice appears to be a simple and effective intervention, it produces a significant population of soy and other nonstandard formula-fed babies who should be drinking regular formulas. Such changes encourage a belief by parents that their infants are allergic or otherwise abnormal and could have a negative impact on subsequent child development.

Humans↗

Length of stay, jaundice, and hospital readmission.

OBJECTIVE: To evaluate the effect of postnatal age at the time of discharge on the risk of readmission to hospital with specific reference to readmission for hyperbilirubinemia. DESIGN: Case-control study based on chart review. SETTING: Large suburban community hospital in southeastern Michigan, delivering more than 5000 infants annually. PATIENTS: Newborn infants, born between December 1, 1988, and November 30, 1994, who were readmitted to hospital within 14 days of discharge, were compared with a randomly selected control group who were not readmitted. RESULTS: Of 29,934 infants discharged, 247 (0.8%) were readmitted by the age of 14 days. One hundred twenty-seven (51%) were admitted because of hyperbilirubinemia and 74 (30%) with the diagnosis of "rule out sepsis." The factors associated with an increased risk of readmission to the hospital were: infant of diabetic mother [odds ratios (OR), 3.45; 95% confidence limits (CL), 1.39 to 8.60]; gestation < or = 36 weeks (OR, 4.56; CL, 1.45 to 14.33), and 37 1/7 to 38 weeks (OR, 2.95; CL, 1.63 to 5.35) versus > or = 40 weeks; presence of jaundice in the nursery (OR, 1.73; CL, 1.14 to 2.63); breastfeeding (OR, 1.78; CL, 1.13 to 2.81); male sex (OR, 1.58; CL, 1.07 to 2.34); length of stay < 48 hours (OR, 1.91; CL, 1.15 to 3.16) and 48 to < 72 hours (OR, 2.09; CL, 1.25 to 3.50) versus > or = 72 hours. Factors associated with readmission for jaundice were gestation < or = 36 weeks (OR, 13.2; CL, 2.70 to 64.6), 36 1/7 to 37 weeks (OR, 7.7; CL, 2.69 to 22.0), 37 1/7 to 38 weeks (OR, 7.2; CL, 3.05 to 16.97) versus > or = 40 weeks; jaundice during nursery stay (OR, 7.80; CL, 3.38 to 18.0); length of stay < 48 hours (OR, 2.40; CL, 1.09 to 5.30) and 48 to < 72 hours (OR, 3.15; CL, 1.40 to 7.09) versus > or = 72 hours; male sex (OR, 2.89; CL, 1.46 to 5.74); and breastfeeding (OR, 4.21; CL, 1.80 to 9.87). Infants whose length of stay was < 48 hours were at no greater risk for readmission for jaundice or other causes than those whose length of stay was > or = 48 hours to < 72 hours. CONCLUSIONS: Discharge at any time < 72 hours significantly increases the risk for readmission to hospital and the risk for readmission with hyperbilirubinemia when compared with discharge after 72 hours. The American Academy of Pediatrics recommends that infants discharged < 48 hours should be seen by a health care professional within 2 to 3 days of discharge. Our observations, as well as those of others, suggest that this recommendation should also be extended to those discharged at < 72 hours after birth. One approach to decreasing the risk of morbidity and readmission, particularly from hyperbilirubinemia, would be to help mothers to nurse their infants more effectively from the moment of birth.

Breast Feeding↗

Jaundice in full-term and near-term babies who leave the hospital within 36 hours. The pediatrician's nemesis.

There has been an increase in hyperbilirubinemia in the newborn population and, perhaps, an increase in bilirubin encephalopathy. The early discharge of newborns from hospital has made it necessary for us to reorient our thinking about bilirubin levels in the first 24 to 48 hours of life and alter our approach to follow-up. The pediatrician must evaluate and follow infants who have risk factors for the development of severe hyperbilirubinemia, paying particular attention to the breast-feeding, near-term infant.

Bilirubin↗

Early discharge from the newborn nursery-effect on scheduling of follow-up visits by pediatricians.

OBJECTIVE: To evaluate the impact of shorter hospital stays on the follow-up scheduling of newborn infants by private pediatricians. DESIGN: Five surveys over a period of 18 months with educational intervention. SETTING: Large community hospital well baby nursery. PARTICIPANTS: Twenty private pediatricians who cared for at least 20 newborn infants in the well baby nurseries during 1995. INTERVENTION: Oral and written communications to pediatricians emphasizing the importance of evaluating infants within 2 to 3 days of discharge if the hospital stay was less than 48 hours. MAIN OUTCOME MEASURE: Interval between discharge from the nursery and the scheduled follow-up visit to the pediatrician. RESULTS: In the first two surveys (September 1994 and March 1995) there was no significant difference in follow-up scheduling by pediatricians for those infants discharged <48 hours vs >/=48 hours. Differences were significant in July and November 1995, and in the final survey in March 1996. Nevertheless, in March 1996, 38% of short-stay infants were scheduled to be seen 4 or more days after discharge, and 33% 14 days after discharge. CONCLUSION: Although follow-up practices have changed in response to shorter newborn hospital stays, a significant proportion of pediatricians are not following the American Academy of Pediatrics guidelines for the follow-up of short-stay infants. Whether or not failure to follow these guidelines will lead to an increase in morbidity is unknown.

Age Factors↗

Clinical rounds in the well-baby nursery: treating jaundiced newborns.

Ten pearls (and pitfalls) in the management of the jaundiced newborn: Remember to take a history. Ask about jaundice in previous siblings and check family ethnicity. Don't ignore jaundice in the first 24 hours--it is considered pathologic until proven otherwise. Some normal infants may appear jaundiced and have a bilirubin level of 5 mg/dL at 23 hours and 59 minutes. On the other hand, a bilirubin level of 5 mg/dL at 10 hours is almost certainly pathologic. Use your judgment. Don't treat 35 to 37 week gestation infants as if they were full-term infants. Although these babies are cared for in well-baby nurseries and are generally treated like full-term infants, they are not full term. They are not as vigorous and do not nurse as well as full-term infants. Infants at 37 weeks gestation are four times more likely to have a serum bilirubin level greater than 13 mg/dL than those at 40 weeks gestation. Don't send 35-week gestation infants home before 48 hours. Document your assessment, particularly if the infant is being discharged early. Document the presence or absence of jaundice and its severity. A late rising bilirubin is typical of G6PD deficiency. Think about the ethnic background: G6PD deficiency is much more likely to occur in families from Greece, Turkey, Sardinia, and Nigeria, and particularly in Sephardic Jews from Iraq, Iran, Syria, and Kurdistan. Your practice may not contain many such families but remember in today's world of travel and intermarriage, etc, these genes are ubiquitous and the diagnosis of G6PD deficiency should always be considered in a newborn child with a significant elevation of bilirubin, particularly if it is a male and the rise in bilirubin is of late onset. Don't use homeopathic doses of phototherapy. As with any drug, phototherapy should be provided in a therapeutic dose (see above), but with the light sources commonly used, it is impossible to overdose the patient. Don't ignore a failure of response to phototherapy. If the bilirubin rises despite adequate phototherapy, there must be a reason. Consider the possibility of an unrecognized hemolytic process. Provide timely follow-up. Infants discharged (as most are) before 48 hours should be seen by a health-care professional within 2 to 3 days of discharge. Don't ignore prolonged jaundice. About one in three normal breast-fed infants still will be clinically jaundiced when they are 2 weeks old (two thirds will be biochemically jaundiced). These infants all have indirect hyperbilirubinemia. Occasionally, however, an infant with prolonged jaundice has direct hyperbilirubinemia. In these infants, the diagnosis of biliary atresia or some other cause of cholestatic jaundice must be considered. If the infant is clinically jaundiced beyond age 2 weeks, you should: 1) check the newborn record to make sure that the metabolic screen for hypothyroidism is normal (congenital hypothyroidism is a cause of indirect hyperbilirubinemia), and 2) ask the mother about the color of the urine and stool. If the baby's stools are pale or the urine is dark yellow, you must get a direct bilirubin to rule out cholestasis. If there is direct hyperbilirubinemia, a urine dipstick will identify the presence of bile (bilirubin). If the color of the urine and stool are normal (by history), it is reasonable to follow the child for another week. However, any infant who is still jaundiced beyond age 3 weeks must have a measurement of direct bilirubin. Don't ignore severe jaundice. If the bilirubin is sufficiently elevated, kernicterus can occur in a healthy, breast-fed infant.

Bilirubin↗

Kernicterus in otherwise healthy, breast-fed term newborns.

OBJECTIVE: To document the occurrence of classical kernicterus in full-term, otherwise healthy, breast-fed infants. METHODS: We reviewed the files of 22 cases referred to us by attorneys throughout the United States during a period of 18 years, in which neonatal hyperbilirubinemia was alleged to be responsible for brain damage in apparently healthy, nonimmunized, full-term infants. To qualify for inclusion, these infants had to be born at 37 or more weeks' gestation, manifest the classic signs of acute bilirubin encephalopathy, and have the typical neurologic sequelae. RESULTS: Six infants, born between 1979 and 1991, met the criteria for inclusion. Their peak recorded bilirubin levels occurred 4 to 10 days after birth and ranged from 39.0 to 49.7 mg/dL. All had one or more exchange transfusions. One infant had an elevated reticulocyte count (9%) but no other evidence of hemolysis. The other infants had no evidence of hemolysis, and no cause was found for the hyperbilirubinemia (other than breast-feeding). CONCLUSIONS: Although very rare, classic kernicterus can occur in apparently healthy, full-term, breast-fed newborns who do not have hemolytic disease or any other discernible cause for their jaundice. Such extreme elevations of bilirubin are rare, and we do not know how often infants with similar serum bilirubin levels escape harm. We also have no reliable method for identifying these infants early in the neonatal period. Closer follow-up after birth and discharge from the hospital might have prevented some of these outcomes, but rare, sporadic cases of kernicterus might not be preventable unless we adopt an approach to follow-up and surveillance of the newborn that is significantly more rigorous than has been practiced. The feasibility, risks, costs, and benefits of this type of intervention need to be determined.

Breast Feeding↗

The effect of breast-feeding frequency on serum bilirubin levels.

OBJECTIVE: Our purpose was to evaluate the effect of breast-feeding frequency on serum bilirubin levels in the first 3 days after birth. STUDY DESIGN: Two hundred seventy-five infants were randomly assigned to a frequent or demand breast-feeding schedule. RESULTS: Infants in the frequent group (n = 131) nursed nine (7.5 to 10.5) times per day (median and inner 80%), and the demand group (n = 143) fed 6.5 (5.5 to 8.0) times per day. The serum bilirubin level was measured in all infants between 48 and 80 hours (median 53 hours, inner 80% 48 to 68 hours) and was 7.4 (1.8 to 10.7) mg/dl in the frequent group and 8.0 (2.9 to 11.2) mg/dl in the demand group (p = 0.103). There was no correlation between the frequency of breast-feeding and the serum bilirubin level. CONCLUSION: Within the range of the frequency of nursing observed in this study, we could not demonstrate a significant effect on serum bilirubin levels in the first 3 days after birth.

Bilirubin↗

Hyperbilirubinemia in the breast-fed newborn: a controlled trial of four interventions.

A controlled clinical trial was conducted to compare the effect of four different interventions on hyperbilirubinemia in 125 full-term breast-fed infants. Of 1685 term infants who met the inclusion criteria, 126 (7.4%) had a serum bilirubin concentration > or = 291 mumol/L (17 mg/dL). When the bilirubin reached this level, babies were assigned at random to one of four interventions: (1) continue breast-feeding and observe; (2) discontinue breast-feeding, substitute formula; (3) discontinue breast-feeding, substitute formula and administer phototherapy; (4) continue breast-feeding, administer phototherapy. The serum bilirubin concentration reached 342 mumol/L (20 mg/dL) in 24% of infants in group 1, 19% in group 2, 3% in group 3, and 14% in group 4. When phototherapy was used, the decline in serum bilirubin was significantly larger and more rapid (compared with no phototherapy). In the majority of breast-fed infants whose serum bilirubin levels reach 291 mumol/L (17 mg/dL) the bilirubin will decline spontaneously and will not reach 342 mumol/L (20 mg/dL). If the infant is significantly jaundiced and a decision is made to intervene, parents can be given a number of options and can make an informed decision regarding which, if any, intervention they prefer.

Analysis of Variance↗

A clinical trial of fiberoptic phototherapy vs conventional phototherapy.

We conducted a randomized, controlled trial to compare fiberoptic phototherapy with conventional phototherapy in healthy jaundiced newborns with birth weights greater than 2500 g. Twelve patients received fiberoptic phototherapy and 14 patients received conventional phototherapy. There were no significant differences between the groups with respect to birth weight, gestational age, feeding method, presence of hemolytic disease, hematocrit, reticulocyte count, or initial serum bilirubin level. Measured irradiance at 425 to 475 nm for conventional phototherapy was greater than that of fiberoptic phototherapy (9.2 +/- 0.9 microW/cm2 per nanometer vs 8.2 +/- 1.2 microW/cm2 per nanometer). Both types of phototherapy lowered the level of serum bilirubin after 18 hours of therapy (fiberoptic group, from 231 +/- 29 to 210 +/- 24 mumol/L; conventional group, from 231 +/- 21 to 188 +/- 26 mumol/L), but the mean serum bilirubin level was lower after 18 hours of therapy in the conventional phototherapy group (188 +/- 26 vs 210 +/- 24 mumol/L). There were no side effects in either group of newborns. Both methods of phototherapy decreased the serum bilirubin level, but conventional phototherapy did so more effectively, probably because of its greater irradiance.

Female↗

Severe retinopathy of prematurity and steroid exposure.

During a 3-year period (1988 through 1990) an increase was observed in the number of infants born at 23- to 26-weeks' gestation who required cryotherapy for severe retinopathy of prematurity (0/20, 1988; 3/14, 1989; 6/18, 1990; P = .015). Inasmuch as this was not related to improved survival, a retrospective case-control study was conducted to try to explain this observation. Of 52 surviving infants who had been born at 23 to 26 weeks' gestation, 9 required cryotherapy and the other 43 served as control subjects. There were no differences between groups in birthweight, gestational age, or the number of infants with hyaline membrane disease, intraventricular hemorrhage, or hydrocephalus. Factors related to the need for cryotherapy included patent ductus arteriosus (P = .046), mechanical ventilation for more than 21 days (P = .045), and the use of steroids for lung disease (P < .001). In this neonatal intensive care unit, steroids are administered according to the attending neonatologist's preference. Inasmuch as steroids are considered only for infants still ventilator dependent at 21 days, this group was analyzed separately (n = 36). Of the 21 factors examined, only the use of steroids for lung disease was associated with the need for cryotherapy (P < .001).

Case-Control Studies↗

Double versus single phototherapy in low birth weight newborns.

Conventional phototherapy systems that simultaneously irradiate the front and the back of the baby lower the serum bilirubin level more rapidly than one-sided systems, but they are impractical. Fiberoptic phototherapy makes it easy to administer conventional phototherapy from above while the infant lies on a fiberoptic phototherapy blanket. Newborns with birth weights less than 2500 g were randomly assigned to receive either single (n = 37) or double (n = 33) phototherapy. The groups were similar in clinical and laboratory characteristics. After 18 hours of therapy the serum bilirubin concentration declined by 31 +/- 11% in the double and 16 +/- 15% in the single phototherapy group (2.9 +/- 1.1 vs 1.6 +/- 1.4 mg/dL), and the difference in the total serum bilirubin levels after 18 hours of therapy was significant (double phototherapy group 7.1 +/- 2.7 mg/dL vs single phototherapy group 8.2 +/- 2.6 mg/dL). After 18 hours of treatment the serum bilirubin level was less than the phototherapy threshold level in 26 of 37 single phototherapy patients vs 32 of 33 double phototherapy patients. Double phototherapy was well tolerated. It is concluded that this type of double phototherapy is more effective than single phototherapy in low birth weight newborns. Double phototherapy may be useful when it is necessary to reduce an elevated serum bilirubin level as rapidly as possible or when the bilirubin level is rising with single phototherapy.

Female↗