Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial.

BACKGROUND: Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS: In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS: We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. CONCLUSIONS: Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.

Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

After publication of our article [1], the authors have reported mathematical errors made in the sample size calculation for this cluster randomized controlled trial (cRCT) (Benzies et al. 2017).

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

BACKGROUND: Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. METHODS: We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. DISCUSSION: Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

Does primary surgical closure of the patent ductus arteriosus in infants <1500 g or ≤32 weeks' gestation reduce the incidence of necrotizing enterocolitis?

BACKGROUND: The hemodynamic perturbation related to patent ductus arteriosus (PDA) is associated with a higher risk of necrotizing enterocolitis (NEC). OBJECTIVE: To determine whether primary surgical closure, as compared with treatment with indomethacin or exposure to prophylactic indomethacin, reduces the incidence of NEC in preterm infants <1500 g and/or ≤32 weeks' gestation with clinically and echocardiogram-identified PDA. METHODS: The literature was reviewed using the methodology for systematic reviews for the Consensus of Science adapted from the American Heart Association's International Liaison Committee on Resuscitation. RESULTS: Ten studies were reviewed. The incidence of NEC was not lower in infants who underwent primary surgery for closure of the PDA compared with infants treated with indomethacin or infants exposed to prophylactic indomethacin (level of evidence 2). CONCLUSION: Primary surgical closure of the PDA cannot be recommended as an intervention to decrease the incidence of NEC in infants <1500 g and/or ≤32 weeks' gestation. BACKGROUND: The hemodynamic perturbation related to patent ductus arteriosus (PDA) is associated with a higher risk of necrotizing enterocolitis (NEC). OBJECTIVE: To determine whether primary surgical closure, as compared with treatment with indomethacin or exposure to prophylactic indomethacin, reduces the incidence of NEC in preterm infants <1500 g and/or ≤32 weeks' gestation with clinically and echocardiogram-identified PDA. METHODS: The literature was reviewed using the methodology for systematic reviews for the Consensus of Science adapted from the American Heart Association's International Liaison Committee on Resuscitation. RESULTS: Ten studies were reviewed. The incidence of NEC was not lower in infants who underwent primary surgery for closure of the PDA compared with infants treated with indomethacin or infants exposed to prophylactic indomethacin (level of evidence 2). CONCLUSION: Primary surgical closure of the PDA cannot be recommended as an intervention to decrease the incidence of NEC in infants <1500 g and/or ≤32 weeks' gestation.

HISTORIQUE: La perturbation hémodynamique liée à la persistance du canal artériel (PCA) s'associe à un risque plus élevé d'entérocolite nécrosante (ECN). OBJECTIF: Déterminer si la fermeture chirurgicale primaire par rapport au traitement à l'indométhacine ou à l'exposition à une prophylaxie à l'indométhacine réduit l'incidence d'ECN chez les prématurés de moins de 1 500 g ou d'un maximum de 32 semaines d'âge gestationnel ayant une PCA diagnostiquée sur le plan clinique et par échocardiogramme. MÉTHODOLOGIE: Les chercheurs ont analysé les publications au moyen de la méthodologie des analyses systématiques pour le Consensus of Science adaptées du comité de liaison internationale sur la réanimation de l'American Heart Association. RÉSULTATS: Les chercheurs ont analysé dix études. L'incidence d'ECN n'était pas plus faible chez les nourrissons qui avaient subi une chirurgie primaire pour fermer une PCA que chez les nourrissons traités à l'indométhacine ou exposés à une prophylaxie à l'indométhacine (qualité des preuves 2). CONCLUSION: La fermeture chirurgicale primaire de la PCA ne peut être recommandée pour réduire l'incidence d'ECN chez les nourrissons de moins de 1 500 g ou d'un maximum de 32 semaines d'âge gestationnel.

Does the use of primary continuous positive airway pressure reduce the need for intubation and mechanical ventilation in infants ≤32 weeks' gestation?

BACKGROUND: Ventilator-induced lung injury is a recognized risk factor for bronchopulmonary dysplasia. OBJECTIVE: To determine whether primary continuous positive airway pressure (CPAP), defined as CPAP without previous endotracheal intubation for any indication, can reduce the need for intubation and mechanical ventilation in infants born at ≤32 weeks' gestational age. METHODS: The literature was reviewed using the methodology for systematic reviews for the Consensus on Resuscitation Science adapted from the American Heart Association's International Liaison Committee on Resuscitation. RESULTS: Fourteen studies were reviewed. Eleven studies provided varying degrees of supportive evidence (level of evidence 3 to 4) that the use of primary CPAP can reduce the need for intubation and mechanical ventilation. CONCLUSION: The use of CPAP as a primary intervention and mode of respiratory support is an option for infants ≤32 weeks' gestation, but avoidance of intubation and mechanical ventilation is more likely in mature infants >27 weeks' gestation.

Regional neonatal oral feeding protocol: changing the ethos of feeding preterm infants.

The Calgary Health Region Neonatal Oral Feeding Protocol is the culminating work of a broad range of healthcare professionals, including staff nurses, nurse practitioners, nurse educators, nurse managers, dietitians, lactation consultants, clinical nurse specialists, and occupational therapists. The protocol represents a synthesis of research evidence and expert opinion pertaining to the introduction and management of oral milk feedings for high-risk infants in the neonatal intensive care unit. This evidence-based neonatal oral feeding protocol is presented to share knowledge and skill required to create positive feeding experiences while assisting high-risk infants to achieve full oral feedings. Goals of this project include promoting consistent neonatal nursing feeding practices and changing the ethos in relation to feeding interactions between caregiver and infant in the neonatal intensive care unit. This culture change will assist nurses to identify what is unique about their professional practice, which is of particular importance given the skill mix resulting from hospital understaffing and a growing nursing workforce shortage.