Evaluating the effect of Family Integrated Care on maternal stress and anxiety in neonatal intensive care units.

Objective: To identify how Family Integrated Care (FICare) affected maternal stress and anxiety. Study Design: This secondary analysis of the FICare cluster randomised controlled trial included infants born between 1 April 2013 and 31 August 2015 at ≤33 weeks' gestation. Mothers completed the PSS:NICU and STAI questionnaires at enrolment and study day 21. Results: 1383 mothers completed the surveys at one or both time-points. The mean PSS:NICU and STAI scores at day 21 were significantly lower in the FICare mothers than controls (PSS:NICU mean [standard deviation] FICare 2.32 [0.75], control 2.48 [0.78], p = 0.0005; STAI FICare 70.8 [20.0], control 74.2 [19.6], p = 0.0004). The sights and sounds, looks and behaviour, and parental role PSS:NICU subscales and the state and trait STAI subscales were all significantly different between FIC are and controls at day 21. The magnitude of change in all stress and anxiety subscales was greater in the FICare group than controls. These differences remained significant after adjustment for confounders with the greatest change in the parental role (least-squares mean [95% confidence interval] FICare -0.65 [-0.72, 0.57], control -0.31 [-0.38, -0.24], p < 0.0001) and state anxiety subscales. Conclusion: FICare is effective at reducing NICU-related maternal stress and anxiety.

Family Integrated Care for Preterm Infants in China: A Cluster Randomized Controlled Trial.

OBJECTIVE: To explore whether family integrated care (FICare) is feasible and improves the outcomes of preterm infants in China. STUDY DESIGN: This was a multicenter prospective cluster-randomized controlled trial comparing FICare and standard care. The primary outcome was length of stay (LOS). Secondary outcomes were nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain. Outcomes were compared using univariate and multivariable analyses adjusted for potential confounders and clustering. RESULTS: We enrolled 601 preterm infants from 11 neonatal intensive care units (FICare, n = 298; control, n = 303). The unadjusted LOS was 30.81 vs 30.26 days (mean ratio, 1.02; 95% CI, 0.85-1.22; P = .85). After adjustment, outcomes in the FICare group were improved compared with the control group, including LOS (28.26 vs 35.04 days; mean ratio, 0.81; 95% CI, 0.72-0.91), total medical expenditures (mean ratio, 0.69; 95% CI, 0.53-0.90), weight gain velocity (15.73 vs 10.30 g/day; mean difference, 5.43; 95% CI, 3.65-7.21), duration of supplemental oxygen (13.11 vs 21.42 days; mean difference, 0.71; 95% CI, 0.50-1.00), nosocomial infection rates (4.13 vs 5.84/1000 hospital days; mean ratio, 0.67; 95% CI, 0.47-0.96), antibiotic exposure (38.63 vs 57.32/100 hospital days; mean ratio, 0.67; 95% CI, 0.47-0.96), breastfeeding rates (87.25% vs 55.78%; OR, 5.42; 95% CI, 3.25-9.05), and rehospitalization rates (3.65% vs 7.48%; OR, 0.47; 95% CI, 0.28-0.77). At follow-up to 18 months, breastfeeding rates and weight were significantly (P < .05) higher over time in the FICare group. CONCLUSIONS: FICare was feasible in Chinese neonatal intensive care units and was associated with reduced hospital LOS, medical expenditures, and rates of adverse outcomes.

Breaking down barriers: enabling care-by-parent in neonatal intensive care units in China.

BACKGROUND: Denying parents access to their infant in the Neonatal Intensive Care Unit (NICU) is a standard practice in most hospitals across China. Visitation is not usually permitted or may be strictly limited, and NICU care for most neonates is provided by health-care professionals with little participation of the parents. An exception to this rule is the level 2 "Room-In" ward in Qilu Children's Hospital, Shandong University, where parents have 24-hour access to their infants and participate in providing care. METHODS: This retrospective cohort study compared the outcomes of infants who were admitted to the NICU and remained there throughout their stay (NICU-NICU group, n=428), admitted to the NICU and then transferred to the Room-In ward (NICU-RIn group, n=1018), or admitted straight to the Room-In ward (RIn only group, n=629). RESULTS: There were no significant differences in the rates of nosocomial infection, bronchopulmonary dysplasia, intraventricular hemorrhage, and retinopathy of prematurity between the NICU-NICU and NICU-RIn groups. The rate of necrotizing enterocolitis was significantly lower in the NICU-RIn group (P=0.04), while weight gain and duration of hospital stay were significantly higher (both P<0.001). Rates of adverse outcomes were lower in RIn-only infants due to their low severity of illness on admission. CONCLUSIONS: Allowing parents access to their infant in the NICU is feasible and safe in China, and may result in improvements in infant outcomes. Further studies are required to generate stronger evidence that can inform changes to neonatal care in China.

Is family integrated care in neonatal intensive care units feasible and good for preterm infants in China: study protocol for a cluster randomized controlled trial.

BACKGROUND: By changing the paradigm of neonatal intensive care and integrating parents into the care team, the 'family integrated care' (FICare) model developed in Canada ensures that infants receive more consistent care and parents are better able to care for their infants within the neonatal intensive care unit (NICU) and at home. However, Chinese health policy dictates that parents are not allowed into the NICU during their infant's stay, which inhibits this type of parent-infant interaction and may affect infant outcomes. This project aims to demonstrate that allowing parents to care for their newborn infants in the NICU improves the medical outcomes of infants. METHODS/DESIGN: This cluster randomized controlled trial will evaluate the feasibility and efficacy of FICare in six Chinese tertiary-level NICUs in China - three 'intervention' and three 'control' NICUs. The study steps are: (1) planning and preparation; (2) staff recruitment and training; (3) pilot study in two centers; (4) interim analysis and confirmation of sample size for main study; (5) implementation of main study; (6) data analysis and preparation and publication of study reports. The primary outcome measure is duration of hospital stay from admission to discharge. Secondary outcome measures are: (1) clinical outcomes, such as nosocomial infection, (2) weight gain, (3) breastfeeding, (4) time to full feed, and (5) maternal stress. DISCUSSION: This study will assess the feasibility and cost-effectiveness of FICare in China. By establishing that FICare is a practical model of NICU care for stable preterm infants in China, this project will have a significant impact on health outcomes, medical practice and policy, and the cost of medical care. The approach used in this project could be transferable to many other areas of medical care, such as pediatrics, chronic care, and geriatrics. Data in this project can be used to inform health policy in NICUs across China so that parents are allowed to enter the NICU and be at their infant's bedside during the baby's hospitalization, and modifying the design of NICUs in China to facilitate the participation of parents in caring for their newborns. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-14004736.

Prophylactic Interventions in Neonatology: How Do They Fare in Real Life?

OBJECTIVE: This study aims to evaluate the association of prophylactic antenatal steroids, indomethacin, and phototherapy with extremely preterm infant outcomes in a pragmatic setting. STUDY DESIGN: Retrospective study of infants born at <28 weeks gestation and admitted to 26 Canadian Neonatal Network neonatal intensive care units between 2010 and 2012. Mortality, severe neurological injury, retinopathy, necrotizing enterocolitis, bronchopulmonary dysplasia, nosocomial infection, and patent ductus arteriosus ligation rates were compared between infants who received antenatal steroids, prophylactic indomethacin, and/or prophylactic phototherapy and those who did not. RESULTS: Of 3,465 eligible infants, 2,900 (84%) received antenatal steroids, 269 (8%) prophylactic indomethacin, and 403 (12%) prophylactic phototherapy. Associations were observed between antenatal steroids and mortality (adjusted odds ration [aOR] 0.47 [0.33-0.66]) and severe neurological injury (aOR 0.60 [0.46-0.77]), indomethacin and ductus arteriosus ligations (aOR 0.52 [0.31-0.87]), but not severe neurological injury (aOR 1.12 [0.81-1.54]), but phototherapy was not associated with any of the neonatal outcomes despite reductions in bilirubin. CONCLUSION: Antenatal steroids were associated with reduced mortality and neurological injury, prophylactic indomethacin was not associated with reduction in neurological injury and phototherapy was not associated with any improvement in neonatal outcomes. In a pragmatic setting, outside randomized controlled trials, the effectiveness and safety of prophylactic interventions in extremely preterm neonates vary; ongoing monitoring is warranted.

Does the use of glycerin laxatives decrease feeding intolerance in preterm infants?

BACKGROUND: Glycerin laxatives are often prescribed in the neonatal population for meconium evacuation and to promote enteral feeding. However, the literature regarding their effectiveness has not been systematically reviewed. OBJECTIVE: To assess the effectiveness of glycerin enema or suppository in preventing feeding intolerance in preterm infants at ≤32 weeks' gestational age or weighing ≤1500 g at birth. METHODS: The Medline, Embase, Cochrane Library, Scopus and Web of Science databases were searched to identify studies that evaluated glycerin enemas/suppositories for feeding intolerance. Using the Evidence Evaluation Worksheet adapted from the American Heart Association's International Liaison Committee on Resuscitation, eligible studies were scored for quality, level of evidence and direction of support. RESULTS: Two clinical studies that evaluated meconium evacuation and feeding intolerance were included. One study showed no difference in the time to complete meconium evacuation or establishment of full enteral feeds, while the other showed that the times to first meconium passage and full enteral feeding were significantly shorter, and the rate of sepsis was lower in the glycerin enema group. CONCLUSION: The evidence regarding the effectiveness of glycerin laxatives for improving feeding tolerance is inconclusive in infants at ≤32 weeks' gestational age or weighing ≤1500 g at birth.

Outcomes of planned home birth with registered midwife versus planned hospital birth with midwife or physician.

BACKGROUND: Studies of planned home births attended by registered midwives have been limited by incomplete data, nonrepresentative sampling, inadequate statistical power and the inability to exclude unplanned home births. We compared the outcomes of planned home births attended by midwives with those of planned hospital births attended by midwives or physicians. METHODS: We included all planned home births attended by registered midwives from Jan. 1, 2000, to Dec. 31, 2004, in British Columbia, Canada (n = 2889), and all planned hospital births meeting the eligibility requirements for home birth that were attended by the same cohort of midwives (n = 4752). We also included a matched sample of physician-attended planned hospital births (n = 5331). The primary outcome measure was perinatal mortality; secondary outcomes were obstetric interventions and adverse maternal and neonatal outcomes. RESULTS: The rate of perinatal death per 1000 births was 0.35 (95% confidence interval [CI] 0.00-1.03) in the group of planned home births; the rate in the group of planned hospital births was 0.57 (95% CI 0.00-1.43) among women attended by a midwife and 0.64 (95% CI 0.00-1.56) among those attended by a physician. Women in the planned home-birth group were significantly less likely than those who planned a midwife-attended hospital birth to have obstetric interventions (e.g., electronic fetal monitoring, relative risk [RR] 0.32, 95% CI 0.29-0.36; assisted vaginal delivery, RR 0.41, 95% 0.33-0.52) or adverse maternal outcomes (e.g., third- or fourth-degree perineal tear, RR 0.41, 95% CI 0.28-0.59; postpartum hemorrhage, RR 0.62, 95% CI 0.49-0.77). The findings were similar in the comparison with physician-assisted hospital births. Newborns in the home-birth group were less likely than those in the midwife-attended hospital-birth group to require resuscitation at birth (RR 0.23, 95% CI 0.14-0.37) or oxygen therapy beyond 24 hours (RR 0.37, 95% CI 0.24-0.59). The findings were similar in the comparison with newborns in the physician-assisted hospital births; in addition, newborns in the home-birth group were less likely to have meconium aspiration (RR 0.45, 95% CI 0.21-0.93) and more likely to be admitted to hospital or readmitted if born in hospital (RR 1.39, 95% CI 1.09-1.85). INTERPRETATION: Planned home birth attended by a registered midwife was associated with very low and comparable rates of perinatal death and reduced rates of obstetric interventions and other adverse perinatal outcomes compared with planned hospital birth attended by a midwife or physician.

Sodium tanshinone IIA sulfonate increased intestinal hemodynamics without systemic circulatory changes in healthy newborn piglets.

In traditional Chinese medicine, tanshinone IIA is a lipid-soluble component of Danshen that has been widely used for various cardiovascular and cerebrovascular disorders, including neonatal asphyxia. Despite promising effects, little is known regarding the hemodynamic effects of tanshinone IIA in newborn subjects. To examine the dose-response effects of sodium tanshinone IIA sulfonate (STS) on systemic and regional hemodynamics and oxygen transport, 12 newborn piglets were anesthetized and acutely instrumented for the placement of femoral arterial and venous, pulmonary arterial catheters to measure mean arterial, central venous, and pulmonary arterial pressures, respectively. The blood flow at the common carotid, renal, pulmonary, and superior mesenteric (SMA) arteries were continuously monitored after treating the piglets with either STS (0.1-30 mg/kg iv) or saline treatment (n = 6/group). To further delineate the underlying mechanisms for vasorelaxant effects of STS, in vitro vascular myography was carried out to compare its effect on rat mesenteric and carotid arteries (n = 4-5/group). STS dose-dependently increased the SMA blood flow and the corresponding oxygen delivery with no significant effect on systemic and pulmonary, carotid and renal hemodynamic parameters. In vitro studies also demonstrated that STS selectively dilated rat mesenteric but not carotid arteries. Vasodilation in mesenteric arteries was inhibited by apamin and TRAM-34 (calcium-activated potassium channel inhibitors) but not by meclofenamate (cyclooxygenase inhibitor) or N-nitro-l-arginine methyl ester hydrochloride (nitric oxide synthase inhibitor). In summary, without significant hemodynamic effects on newborn piglets, intravenous infusion of STS selectively increased mesenteric perfusion in a dose-dependent manner, possibly via an endothelium-derived hyperpolarizing factor vasodilating pathway.

An evaluation of process and protocols for planned home birth attended by regulated midwives in British Columbia.

Midwifery emerged as a self-regulated profession in British Columbia in the context of a 2-year demonstration project beginning in 1998. The project evaluated accountability among midwives, defined as the provision of safe and appropriate care and maintenance of standards of communication set by the College of Midwives of British Columbia. Adherence to protocols was measured by using documentation designed specifically for the Home Birth Demonstration Project. Hospital and transport records for selected clients were reviewed by an expert committee. Outcomes among Home Birth Demonstration Project clients were compared with outcomes among women eligible for home birth but planning to deliver in hospital. Adherence to clinical and communication protocols was 96% or higher. Planned home birth was not associated with an increase in risk but prevalence of adverse outcomes was too low to be studied with precision. Recommendations of an expert review committee have been implemented or are under review. Midwives have demonstrated a high degree of compliance with reporting requirements and protocols. Comparisons of birth outcomes of planned home versus hospital births, while supporting home birth as a choice for women, were limited in scope and require ongoing study. Integration of home birth has been a dynamic process with guidelines and policy continuing to evolve.

Outcomes of planned home births versus planned hospital births after regulation of midwifery in British Columbia.

BACKGROUND: The choice to give birth at home with a regulated midwife in attendance became available to expectant women in British Columbia in 1998. The purpose of this study was to evaluate the safety of home birth by comparing perinatal outcomes for planned home births attended by regulated midwives with those for planned hospital births. METHODS: We compared the outcomes of 862 planned home births attended by midwives with those of planned hospital births attended by either midwives (n = 571) or physicians (n = 743). Comparison subjects who were similar in their obstetric risk status were selected from hospitals in which the midwives who were conducting the home births had hospital privileges. Our study population included all home births that occurred between Jan. 1, 1998, and Dec. 31, 1999. RESULTS: Women who gave birth at home attended by a midwife had fewer procedures during labour compared with women who gave birth in hospital attended by a physician. After adjustment for maternal age, lone parent status, income quintile, use of any versus no substances and parity, women in the home birth group were less likely to have epidural analgesia (odds ratio 0.20, 95% confidence interval [CI] 0.14-0.27), be induced, have their labours augmented with oxytocin or prostaglandins, or have an episiotomy. Comparison of home births with hospital births attended by a midwife showed very similar and equally significant differences. The adjusted odds ratio for cesarean section in the home birth group compared with physician-attended hospital births was 0.3 (95% CI 0.22-0.43). Rates of perinatal mortality, 5-minute Apgar scores, meconium aspiration syndrome or need for transfer to a different hospital for specialized newborn care were very similar for the home birth group and for births in hospital attended by a physician. The adjusted odds ratio for Apgar scores lower than 7 at 5 minutes in the home birth group compared with physician-attended hospital births was 0.84 (95% CI 0.32-2.19). INTERPRETATION: There was no increased maternal or neonatal risk associated with planned home birth under the care of a regulated midwife. The rates of some adverse outcomes were too low for us to draw statistical comparisons, and ongoing evaluation of home birth is warranted.