Steven Gross

Reducing Premature Infants' Length of Stay and Improving Parents' Mental Health Outcomes With the Creating Opportunities for Parent Empowerment (COPE) Neonatal Intensive Care Unit Program: A Randomized, Controlled Trial

OBJECTIVE. Although low birth weight premature infants and parents are at high risk for adverse health outcomes, there is a paucity of studies that test early NICU interventions with parents to prevent the development of negative parent-infant interaction trajectories and to reduce hospital length of stay. Our objective was to evaluate the efficacy of an educational-behavioral intervention program (ie, Creating Opportunities for Parent Empowerment) that was designed to enhance parent-infant interactions and parent mental health outcomes for the ultimate purpose of improving child developmental and behavior outcomes. DESIGN, SETTING, AND PARTICIPANTS. A randomized, controlled trial was conducted with 260 families with preterm infants from 2001 to 2004 in 2 NICUs in the northeast United States. Parents completed self-administered instruments during hospitalization, within 7 days after infant discharge, and at 2 months corrected age. Blinded observers rated parent-infant interactions in the NICU. INTERVENTION. All participants received 4 intervention sessions of audiotaped and written materials. Parents in the Creating Opportunities for Parent Empowerment program received information and behavioral activities about the appearance and behavioral characteristics of preterm infants and how best to parent them. The comparison intervention contained information regarding hospital services and policies. MAIN OUTCOME MEASURES. Parental stress, depression, anxiety, and beliefs; parent-infant interaction during the NICU stay; NICU length of stay; and total hospitalization were measured. RESULTS. Mothers in the Creating Opportunities for Parent Empowerment program reported significantly less stress in the NICU and less depression and anxiety at 2 months corrected infant age than did comparison mothers. Blinded observers rated mothers and fathers in the Creating Opportunities for Parent Empowerment program as more positive in interactions with their infants. Mothers and fathers also reported stronger beliefs about their parental role and what behaviors and characteristics to expect of their infants during hospitalization. Infants in the Creating Opportunities for Parent Empowerment program had a 3.8-day shorter NICU length of stay (mean: 31.86 vs 35.63 days) and 3.9-day shorter total hospital length of stay (mean: 35.29 vs 39.19 days) than did comparison infants. CONCLUSIONS. A reproducible educational-behavioral intervention program for parents that commences early in the NICU can improve parent mental health outcomes, enhance parent-infant interaction, and reduce hospital length of stay.

The New York State universal newborn hearing screening demonstration project: Ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention

Objective: To determine the ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention through a multi‐center, state‐wide universal newborn hearing screening project. Design: Universal newborn hearing screening was conducted at eight hospitals across New York State. All infants who did not bilaterally pass hearing screening before discharge were recalled for outpatient retesting. Inpatient screening and outpatient rescreening were done with transient evoked otoacoustic emissions and/or auditory brain stem response testing. Diagnostic testing was performed with age appropriate tests, auditory brain stem response and/or visual reinforcement audiometry. Infants diagnosed with permanent hearing loss were considered for hearing aids and early intervention. Ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention were investigated regarding nursery type, risk status, unilateral versus bilateral hearing loss, loss type, loss severity, and state regions. Results: The prevalence of infants diagnosed with permanent hearing loss was 2.0/1000 (85 of 43,311). Of the 85 infants with hearing loss, 61% were from neonatal intensive care units (NICUs) and 67% were at risk for hearing loss. Of the 36 infants fitted with hearing aids, 58% were from NICUs and 78% were at risk for hearing loss. The median age at identification and enrollment in early intervention was 3 mo. Median age at hearing aid fitting was 7.5 mo. Median ages at identification were less for infants from the well‐baby nurseries (WBNs) than for the NICU infants and for infants with severe/profound than for infants with mild/moderate hearing loss, but were similar for not‐at‐risk and at‐risk infants. Median ages at hearing aid fitting were less for well babies than for NICU infants, for not‐at‐risk infants than for at‐risk infants, and for infants with severe/profound hearing loss than for infants with mild/moderate hearing loss. However, median ages at early intervention enrollment were similar for nursery types, risk status, and severity of hearing loss. Conclusions: Early ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention can be achieved for infants from NICUs and WBNs and for infants at risk and not at risk for hearing loss in a large multi‐center universal newborn hearing screening program.

The New York State universal newborn hearing screening demonstration project: outpatient outcome measures.

Objective: To investigate outpatient outcome measures of a multi‐center, state‐wide, universal newborn hearing screening project. Design: Eight hospitals participated in a 3‐yr, funded project. Each hospital designed its own protocol using common criteria for judging whether an infant passed a hearing screening. Infants were tested in the hospital, and those either failing the in‐hospital screening or who were not tested in the hospital (missed) were asked to return 4 to 6 wk after hospital discharge for outpatient rescreening. Those infants failing the outpatient rescreening were referred for diagnostic auditory brain stem response testing. Each hospital used its own audiological equipment and criteria to determine whether a particular infant had a hearing loss. All data were collected and analyzed for individual hospitals, as well as totaled across all hospitals. Data were analyzed in terms of year of program operation, nursery type, and geographic region. Results: Seventy‐two percent of infants who failed the in‐hospital screening returned for outpatient testing. The percentage of in‐hospital fails returning for retesting was significantly higher than the percentage of in‐hospital misses returning for retesting. The percentage of infants returning for retesting increased with successive years of program operation. Some differences were noted in the percentage of infants returning for retesting among hospitals and geographic regions of the state. Some differences in outpatient outcome measures also were noted between infants originally born into the neonatal intensive care unit (NICU) and the well‐baby nursery (WBN). The percentage of infants from the NICU who returned for retesting was slightly higher than that for infants from the WBN. The percentage of infants from the WBN passing the outpatient rescreening was higher than that for the NICU infants. The overall prevalence of hearing loss was 1.96/1000, with that in the NICU being 8/1000 and that in the WBN being 0.9/1000. Positive predictive value for permanent hearing loss based on inpatient screening was approximately 4% and based on outpatient rescreening was approximately 22%. Conclusions: Several outpatient outcome measures changed with successive years of program operation, suggesting that programs improve over time. Also, some outpatient outcome measures differ between NICU and WBN populations. The differences noted across regions of the state in the percentage of infants returning for outpatient retesting require further research to determine whether differences are due to demographic and/or procedural differences.

Evaluation of a long-chain polyunsaturated fatty acid supplemented formula on growth, tolerance, and plasma lipids in preterm infants up to 48 weeks postconceptional age

BACKGROUNDnThe last trimester of pregnancy is a period of rapid accretion of long-chain polyunsaturated fatty acids, both in the central nervous system and the body as a whole. Human milk contains these fatty acids, whereas some preterm infant formulas do not. Infants fed formulas without these fatty acids have lower plasma and erythrocyte concentrations than infants fed human milk. Preclinical and clinical studies have demonstrated that single-cell sources (algal and fungal) of long-chain polyunsaturated fatty acids are bioavailable. A balanced addition of fatty acids from these oils to preterm formula results in blood fatty acid concentrations in low birth weight infants comparable to those of infants fed human milk.nnnMETHODSnIn the present study the growth, acceptance (overall incidence of discontinuation, reasons for discontinuation, overall incidence and type of individual adverse events), and plasma fatty acid concentrations were compared in three groups of infants fed a long-chain polyunsaturated fatty acid-supplemented preterm infant formula, an unsupplemented control formula, or human milk. The study was prospective, double-blind (formula groups only), and randomized (formula groups only). Two hundred eighty-eight infants were enrolled (supplemented formula group, n = 77; control formula group, n = 78; human milk group, n = 133).nnnRESULTSnAnthropometric measurements at enrollment, at first day of full oral feeding, and at both 40 and 48 weeks postconceptional age did not differ between the formula groups, whereas the human milk-fed group initially grew at a lower rate. The incidence of severe adverse events was rare and not significantly different between formula groups. The groups fed either human milk or supplemented formula had long-chain polyunsaturated fatty acid concentrations higher than those in the control formula group.nnnCONCLUSIONSnThe results of this study demonstrate the safety and efficacy of a preterm formula supplemented with long-chain polyunsaturated fatty acids from single-cell oils.

New York State universal newborn hearing screening demonstration project: effects of screening protocol on inpatient outcome measures.

Objective: To examine differences among various test protocols on the fail rate at hospital discharge for infants in the well‐baby nursery (WBN) and neonatal intensive care unit (NICU) who received hearing screening through a universal newborn hearing screening demonstration project. Design: The outcomes of several screening protocols were examined. Two technologies were used: transient evoked otoacoustic emissions (TEOAEs) alone or in combination with the auditory brain stem response (ABR). The performance of test protocols in both nurseries within eight hospitals was examined over a 2‐ to 3‐yr period. In the WBN, six hospitals used a screening protocol of TEOAE technology first followed by an ABR (automated or conventional) technology screening for newborns who referred on TEOAE screening. Two hospitals used TEOAE only in the WBN. Seven hospitals used screening protocols in the NICU that used a combination of TEOAE and ABR technologies (TEOAE technology administered first or second, before or after TEOAE, or TEOAE and ABR tests on all infants). Only one hospital used TEOAE technology exclusively for hearing screening. Results: Significant differences among screening protocols were found across hospitals in the first, second, and third years of the program. The combination of TEOAE technology and ABR technology (a two‐technology screening protocol) resulted in a significantly lower fail rate at hospital discharge than the use of a single‐technology (TEOAE). Fail rates at discharge were twice as high using the one‐technology protocol versus two‐technology protocol, even when the best outcomes from program year 3 were considered exclusively. Results of two‐technology versus one‐technology protocols were similar in the NICU. Use of a second technology for screening TEOAE fails significantly reduced every hospital that used the protocols fail rate at discharge. Conclusions: A two‐technology screening protocol resulted in significantly lower fail rates at hospital discharge in both the WBN and NICU nurseries than use of a single‐technology (TEOAE) hearing screening protocol.

A Multicenter Long-term Safety and Efficacy Trial of Preterm Formula Supplemented with Long-chain Polyunsaturated Fatty Acids

BackgroundThe tissue accretion of long-chain polyunsaturated fatty acids is compromised in infants born prematurely. Human milk contains long-chain polyunsaturated fatty acids, but most preterm infant formulas do not. The long-term effects of preterm formula supplemented with arachidonic acid and docosahexaenoic acid, in proportions typical of those in human milk, were therefore investigated. MethodsIn this double-blind, randomized study, 288 preterm infants received experimental formula (n = 77), unsupplemented (control) formula (n = 78), or human milk (n = 133) until 48 weeks postconceptional age (PCA). Term formula, without supplemental long-chain polyunsaturated fatty acids, was administered from 48 to 92 weeks PCA to formula-fed infants and to infants weaned from human milk. Anthropometric and fatty acid data were assessed by using analysis of variance. ResultsAt 92 weeks PCA, no statistically significant anthropometric measurement differences were found except for midarm circumference, which was smaller in human milk–fed infants than in those fed formula. Phospholipid concentrations were similar in the experimental and human milk–fed groups, and docosahexaenoic acid levels were significantly greater than in the control group. The types and incidences of adverse events were similar among the feeding groups. ConclusionsThe results of this study demonstrate the efficacy and long-term safety of preterm formula supplemented with long-chain polyunsaturated fatty acids.

Growth in human milk-Fed very low birth weight infants receiving a new human milk fortifier.

Background/Aims: Human milk fortification has been advocated to enhance premature infants’ growth. We, therefore, undertook this study of a new human milk fortifier containing more protein than a reference one. Methods: Open, randomized, controlled, multiclinic trial, with weekly growth parameters and safety evaluations in premature infants <1,500 g. Results: The 2 groups did not differ in demographic and baseline characteristics. The adjusted daily milk intake was significantly higher in the infants fed reference human milk fortifier (n = 29; 154.2 ± 2.1 vs. 144.4 ± 2.5 ml/kg/day, mean ± SE; p < 0.05). Both human milk fortifiers produced increases over baseline in weight, length, and head circumference, with greater gains observed in the new human milk fortifier-fed infants for the former two parameters (weight gain 26.8 ± 1.3 and 20.4 ± 1.2 g/day, p < 0.05; head circumference 1.0 ± 0.1 and 0.8 ± 0.1 cm/week; length 0.9 ± 0.1 and 0.8 ± 0.1 cm/week, respectively). Serum chemistries were normal and acceptable for age. Study events were typical for premature infants and similar in both groups. Conclusions: This new human milk fortifier had comparable safety to the reference human milk fortifier and promoted faster weight gain and head circumference growth.

Mumps exposure of a health care provider working in a neonatal intensive care unit leads to a hospital-wide effort that prevented an outbreak.

BACKGROUNDnControl measures were instituted in a neonatal intensive care unit (NICU) in Syracuse, New York, when a neonatologist became ill with mumps after returning from Africa. Two health care providers (HCPs) who worked with the neonatologist developed parotitis within 13 days of exposure. Outbreak control included furloughing the neonatologist and the 2 HCPs until after 5 days of the onset of parotitis, cohorting and isolating all exposed infants in the NICU, and implementing droplet precautions. All susceptible HCPs were immunized, and all HCPs were required to wear surgical masks when within 3 feet of patients.nnnRESULTSnFive HCPs developed parotitis. The neonatologist and 2 of the HCPs were confirmed cases, and 2 other HCPs did not meet the case definition. Twenty-six HCPs who worked in other units of the hospital besides the NICU developed nonspecific signs and symptoms of illness. Of the 2,904 HCPs tested, 287 (10%) had negative antibody results, and 153 (8%) were age 40 years or older. Of the 287 HCPs with negative antibody titers, 200 (70%) received the mumps-measles-rubella vaccine in response to this effort. No cases of mumps were reported in exposed infants, children, or adult patients during the time of exposure.nnnCONCLUSIONnInfection control efforts, including vaccinating susceptible HCPs and instituting droplet precautions, might have prevented mumps infection in the NICU patients.

Low rate of necrotizing enterocolitis in extremely low birth weight infants using a hospital-based preterm milk bank

ObjectiveWe examined the effect of two strategies to prevent necrotizing enterocolitis (NEC) in extremely low birth weight (ELBW) infants—adherence to a standardized feeding protocol and use of a hospital-based milk bank to provide exclusive preterm human milk feedings.Study designWe conducted a single-center observational study from 2010 to 2015. Infants received preterm human milk, initially trophic feeds from days 7 to 14 after birth, followed by advancement of 15u2009mL/kg/day to reach a goal of 180u2009mL/kg/day. Fortification was used selectivelyxa0for weight gain <u200915u2009g/kg/day. We determined the incidence of NEC, other morbidities, and growth.ResultsThe cohort included 398 ELBW infants who survived to day 14 without congenital anomalies. Mean gestational age was 26.2u2009±u20091.9 weeks. Maternal milk was used as the sole feeding in 62% of infants; preterm donor milk was used solely or as supplement in 29%. Full feeds were reached at a median of 27 (IQR 23, 33) days. Four infants (1%) developed NEC.ConclusionUse of standardized feedings with a hospital-based milk bank is associated with an incidence of NEC lower than previously reported.