Elaboration and implementation of a protocol for the Golden Hour of premature newborns using an Implementation Science lens

Objective: describe the process of designing and implementing a care protocol for the first hour of life of premature newborns. Method: a participatory research study using an implementation science framework, the Consolidated Framework for Implementation Research (CFIR) was employed to determine drivers and facilitators of implementation success of the Golden Hour protocol for newborns at a large university hospital in southeastern Brazil. A multi-professional team, including first line providers and managers participated in six stages of quality improvement: situational diagnosis; protocol elaboration; training protocol implementation; barrier and facilitator assessment; and protocol monitoring and review. Qualitative and monitoring data collected across these six stages were analyzed using descriptive statistics and content analysis. Results: the institution’s Golden Hour protocol was organized by the multi-professional team based on a collective and dialogical approach. The protocol prioritized the infant’s cardiopulmonary stability, as well as prevention of hypothermia, hypoglycemia and infection. After four months of implementation, the care team was evaluated the protocol as a good quality intervention, necessary for the service, low-cost and not very complex. One suggested improvement recommended was to carry out refresher training to address staff turnover. Conclusion: implementation of the Golden Hour protocol introduced an appropriate and feasible neonatal care quality improvement process, which requires periodic refresher training to ensure greater adherence and better neonatal results.


Introduction
Premature birth is an important risk factor for newborn (NB) morbidity and mortality. The neonatal period presents substantial risk of developing complications in the neonatal period, mainly for extremely premature or extremely low-birth weight infants. Such complications are correlated with longer hospitalization times and unfavorable outcomes, such as sequelae or death (1)(2) .
The occurrence of increasingly premature births and the reduction in the viability limits are challenges for professionals who assist NBs. The first 60 minutes of a premature NB's life, referred to as the Golden Hour, are essential for maintaining NB life. The Golden Hour strategy focuses on specific goals, developed in Neonatology (2)(3) .
The Golden Hour strategy proposes a more efficient service based on evidence, structuring multidisciplinary teamwork and effective communication; reinforcing integrated work through standardization of care and the use of clinical protocols (4)(5) . During the Golden Hour, care team actions are carried out to effectively stabilize the health of premature newborns, via preparation for delivery, timely umbilical cord clamping, maintenance of normothermia, monitoring and provision of adequate respiratory support, transfer to the neonatal unit, vascular access and prevention of hypoglycemia, among other clinical care measures (3)(4)(5) .
A number of studies have already shown the positive impact of implementing Golden Hour protocols in the prevention and reduction of hypothermia and hypoglycemia rates in the care of preterm newborns (PTNBs) through standardization of care (1,(6)(7) . Offering assistance informed by scientific evidence, the Golden Hour protocols contribute to the systematic use of effective interventions, standardization of clinical practices across providers and settings and rational organization of services, as well as contribute to professionals' ethical awareness (1,3,(8)(9) .
Quality improvement interventions can be driven by implementation research studies, which adopt and integrate evidence-based practices, and study the main drivers of adoption, implementation and sustainability of these practices, with the aim of improving patient and population health outcomes (3,(10)(11) .
The effective integration of evidence-based interventions into neonatal care, including adoption of advanced technologies have contributed to a significant reduction in neonatal morbidity and mortality rates globally (1)(2) . Implementation settings which focus on continual improvements in quality have the potential for continually better survival outcomes in PTNBs (3)(4)(5)(6)(7)(9)(10)(11) .
Understanding the importance of these findings, and considering that the study institution did not have a defined and implemented Golden Hour protocol for PTNBs, the elaboration and implementation of a protocol duly adapted to the local context was deemed important to favor organization, integration and standardization of care for premature infants in their first hour of life, contributing to patient safety and favoring the adoption, dissemination and maintenance of the recommended care measures.
Thus, this study aimed to describe the elaboration and implementation process of a care protocol for the first hour of life of premature newborns.

Type of study
A participatory research study was conducted, using the Consolidated Framework for Implementation Research (CFIR) as a lens to guide the design and implementation of the multi-professional care protocol for the Golden Hour. The CFIR 1.0 domains and constructs are available at http://www.cfirguide.org/constructs.html.
The following CFIR domains were used: characteristics of the intervention, characteristics of the individuals and the organization, and the implementation process.

Study locus
The study was carried out in a neonatal unit of a university hospital belonging to the hospital network of the Brazilian Company of Hospital Services (Empresa Brasileira de Serviços Hospitalares, EBSERH), in the city of Vitória, state of Espírito Santo, Brazil.

Participants
The study participants included members of the multiprofessional team specifically physicians, nurses, nursing technicians and physiotherapists, responsible for assisting PTNBs. The professionals who were away from care duties for any reason during the study period were excluded.

Data collection
The study was carried out in six stages, organized within the continuous improvement cycle (Plan, Do, Check, Act), also known as PDCA cycle: situational diagnosis; elaboration of the protocol; training sessions; implementation of the protocol; survey of barriers and facilitators in the implementation process; and monitoring and review of the protocol.
In the first stage, an initial situational diagnosis was carried out using data collected from medical records www.eerp.usp.br/rlae weeks of gestation at the study hospital and admitted to the Neonatal Unit during the second semester of 2019.
A data collection instrument was prepared and used by the researcher, with data based on national and international recommendations and separated into the following groups: general data; preparation for assistance; care immediately after delivery; transport; and admission to the neonatal unit. The data were collected by the researcher herself from March to April 2020.
In the second stage, a working group was assembled to operationalize the protocol and plan implementation activities. During this stage, the professionals invited pandemic, data was collected virtually -via three virtual group meetings were held to discuss the protocol, as well as two individual assessments, by email, between June 2020 and May 2021. The Teams platform was used for the virtual meetings, which were recorded.
The study objectives were presented in the first meeting, as well as data on the situational diagnosis of  (14) ; recommendations for Resuscitation of Premature Infants < 34 weeks in the delivery room: 2016 Guidelines of the Brazilian Society of Pediatrics (15) and Transportation of high-risk newborns: 2017 Guidelines of the Brazilian Society of Pediatrics (16) ; guidelines contained in the 2019-2021 Neonatal Guidelines from the National Health Service (NHS) (17) and adapted to the local reality; and in the Santa Joana Group material called Assistance to preterm NBs in the neonatal Intensive Care Unit (ICU): 2019 manual of practical courses of action (18) .
The protocol structure followed the standardization of the quality sector of the hospital institution under study.
The group meetings lasted from one to two hours. After the second and third meetings, adjustments were made to the protocol content and emailed to the participants for an individual evaluation. At the end of this evaluation period, the content was updated with the suggestions received and emailed for a final assessment, in which the participants indicated whether they fully/partially agreed or if adjustments were required, and cited the suggestions; or even if they fully disagreed. After feedback, the protocol was finalized and forwarded to the hospital's quality sector, which made the protocol available on the institution's Intranet.
In the third stage, the training sessions was carried out along with the unit's permanent education program.
The training sessions were publicized electronically to the staff of the neonatal, maternal-child and surgery units, and took place from July to August 2021. They were carried out by the researcher and recorded using the Teams platform.
The protocol was presented during the training, highlighting the objectives and changes in the care provided, the flowchart, the monitoring instrument and, at the end, a space was opened for discussion and suggestions.
At the end of the training, an evaluation of the professionals' motivation level (high, average, low) before and after the training by the institution was carried out.
Other aspects addressed in the evaluation were content adequacy and its applicability to practice and the extent to which new knowledge was transferred to learners; the instructor's performance, his/her knowledge, didactics and communication; infrastructure and logistics, facilities and devices and hour load; the participants' performance; the strengths and weaknesses of the activity; and any additional suggestions or comments.
In the week before implementation, an in-service With these data, a monitoring diagnosis was made, verifying execution of the actions established in the protocol. After analyzing the data, the working group met in person, discussed the results obtained and reviewed the protocol, making necessary changes and inclusions.
A voice recorder was used for this meeting.
To enhance use of the protocol, two warning signs were prepared for the team and an illustrative flowchart, in banner format was printed, to be displayed in the neonatal unit.

Data analysis
The quantitative data were analyzed using descriptive statistics. As for the qualitative data, the recordings of the focus group discussions were transcribed and categorical content analysis was used to organize them into three phases: 1) pre-analysis; 2) exploration of the material; and 3) treatment of the results, inference and interpretation (19) .
The working group participants were identified as code means that part of the statement was omitted.

Ethical aspects
The project was approved by the Research Ethics Committee under number 1,794,528. The participants were informed about the study and signed the Free and Informed Consent Form after reading it. They were also informed about their right to refuse to participate or to refuse to answer any questions, interrupt the interview or withdraw from the study, at any moment, without providing any information or affecting their service.

Results
In the first stage, for the initial situational diagnosis, 32 medical records of preterm newborns with gestational age (GA) < 34 weeks were evaluated. Regarding the care provided, it was possible to observe that 50% of the PTNBs required resuscitation; 65.6 % were admitted During the meetings, the working group pointed out the importance of elaborating a protocol adequate to the local reality and their concern with the scope and inclusion and exclusion criteria for using the protocol. The bundle designed for monitoring the activities also underwent minor adjustments in its content.
After its elaboration, the protocol was evaluated by the working group participants. Seven participants stated that they agreed with the material and some suggestions were made and accepted, three subjects fully agreed with the material, and two participants did not issue any opinion.
In the third stage, with the protocol corrected and approved by the working group, the online training sessions were carried out. 59 professionals participated in the training: 20 nurses, 18 nursing technicians, 10 physiotherapists, six physicians, two resident physicians and two speech therapists (all working in the neonatal unit), and a nurse from the Nursing Division. The reaction assessment was answered by 42 participants, and the high motivation level rose from 59.5% before the training to 81% after the sessions.
The importance of the protocol and training was highlighted in the participants' testimonies.
(...) we do many things, but now, with knowledge, we're even thirstier to do. We can start right? (T7)

Most of the time we do the protocol, but we don't follow this
training, you know, and I think that makes all the difference (T9).

(...) it'll be a great benefit for us to improve what we already do (T14).
A total of 87 professionals participated in the in-service guidance to implement the protocol: 65 professionals from the neonatal unit, five from the pre-delivery and obstetric center, and 17 from the surgical center. However, the surgical center professionals who work in the night shift were not approached.
In the fourth stage, to start using the protocol, an adjustment was made to the Perinatal Clinical History form, including data on maternal temperature at the time of delivery, NB temperature and risk score for transfer.
In each transfer incubator, the table for calculating the Morbidity Risk Score during Intra-Hospital Transfer (ERTIH-Neo) was fixed and made available in the unit printed with the admission bundle.
In the fifth stage, after four months of having implemented the protocol, a semi-structured questionnaire was applied, organized under the CFIR domains, which was answered by 44 professionals from the neonatal unit, including nurses, physicians, physiotherapists and nursing technicians. The results are shown in Table 1. When evaluating the protocol, the participants who partially agreed that it was a need for the service/ institution and adapted to meet the local reality mentioned the need to expand its use to other services, the benefit for the PTNB's family and issues related to human resources, to the physical structure and to the protocol attributions.
In the complexity item, some participants agreed that the protocol is very complex but, even so, they considered the protocol necessary; others linked complexity of the protocol to the procedures and performance of the team.
Regarding the investments, the participants highlighted the professionals' educational investment; five participants did not answer and, of these, some stated not having sufficient knowledge to answer the question.
When evaluating the characteristics of the individuals, 79.5% of the participants answered that the neonatal unit professionals supported use of the protocol. Those who answered that they partially agreed addressed the professionals' behavior and lack of knowledge related to the protocol.
Through the semi-structured questionnaire, the participants reported possible facilitators and barriers in the protocol implementation process. Figure 1 presents the facilitators and barriers from the professionals' perspective.

Discussion
In Brazil, more than 308,000 premature births were recorded in 2020; among these, 13,646 corresponded to NBs with gestational ages between 22 and 27 week (20) .
In this study, the data demonstrate that premature births of extreme PTNBs, specifically those requiring intubation and advanced resuscitation, increases the need for more complex interventions for their clinical stabilization.
International studies highlight the importance of implementing protocols, bundles or checklists as a strategy for improving the care provided to PTNBs (3)(4)(5)(9)(10) .
Following the international recommendations, the protocol elaborated in this study was organized under four main pillars: cardiopulmonary stabilization, and prevention of hypothermia, hypoglycemia and infection. Actions such as setting the ambient temperature, using a heated field, equipment for fractional oxygen supply and agility in obtaining venous access are important to meet these pillars, as observed in other studies (3)(4)(9)(10) .
For the use of these strategies to achieve positive results, it is crucial to have a team duly prepared for this assistance, as PTNBs < 34 weeks may require resuscitation and supplemental oxygen supply (21) . In this study, 50% of the PTNBs required resuscitation in the delivery room, at the initial diagnosis. of PTNBs and that it is a predictive factor of morbidity and mortality, regardless of gestational age. Heat loss cannot be overcome by heat production, mainly in premature infants, and the team must carry out interventions for thermal control while caring for the PTNB (4,6,(22)(23) .
At a high-performance NICU, the prevention of hypoglycemia and infection and delayed cord clamping are also important aspects of care to be provided to PTNBs after birth (3,5,10) . For the prevention of infections, it is necessary to adopt aseptic measures in PTNB handling, as well as adequate administration of antibiotics (3) .
The data after implementation of the protocol infants, using standardization of care in the delivery room and team training (7) . International studies report improvements in PTNB glycaemic and temperature control after implementation of the Golden Hour Protocol (3)(4)(5)(6)10,23) , supporting the results of this study.
Corroborating our findings, two international studies also found a prolonged time to obtain venous access, administration of fluids and antibiotics, routine use of umbilical catheter, and low use of peripheral venous catheter (3,5) . Considering the recommendation of peripheral venous access and subsequent umbilical catheterization to prevent hypoglycemia related to the delay in fluid supply (1,23) , the team adopted this approach in the protocol. and avoiding decline of the proposal (10,23,25) .
Another relevant factor for maintaining good practices is monitoring intervention implementation. Some successful improvements may be lost over time, resulting in team members returning to the use of old practices.

Conclusion
The institution's first Golden Hour protocol was The protocol for assisting PTNBs with less than 34 weeks during the first hour of life has already been implemented and is in use in the study site. Compliance with all actions within the protocol has not yet been measured, but its adoption already represents an improvement in terms of quality, as the unit did not have systematic way to manage PTNB care prior to the study.
Thus, with protocol implementation, a process to change professionals' behavior and knowledge in relation to quality and safety of the PTNB care provided at the Golden Hour was initiated.
Consolidation of the evidence-based care recommended in the protocol requires continuing education of the neonatal team and other sectors involved, in order to assist in adherence and in achieving better results, which may be expanded to include professors and health students in the future. It is also noted that the acquisition of materials favors the achievement of better results.