Study setting {9}
This study is a multicenter study involving 2 public tertiary hospitals located in two of the six geopolitical zones in Nigeria.[24-25] The selected tertiary hospital includes University College Hospital Ibadan and The Federal Medical Centre Kastina, Kastina state as shown in the map below.
Eligibility criteria {10}
Inclusion Criteria
1.All newborns admitted into the selected study sites whose parents /caregivers gave their informed consent to participate in the study.
Exclusion criteria:
1.Babies taken custody by institution such as motherless home or by government agencies for legal reasons.
- Babies whose parents/ caregivers fail to give consent for the study
Who will take informed consent? {26a}
Prior to enrolment into the study, the research would be explained to parents/caregivers by the investigator who will obtain written informed consent. Parents/caregivers will be informed of their freedom to refuse to take part in the study without any negative consequences to them or their wards in the course of treatment.
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Additional consent would be obtained for data availability for secondary analysis and for ancillary studies in the future.
Interventions
Explanation for the choice of comparators {6b}
The comparator is the standard of care for all babies admitted to the newborn units in the study sites. The standard of care is discharge by the attending Physician according to the Hospital Unit Protocol.
Interventiondescription {11a}
The treatment arm in this trial is a faith-based intervention (FBI). The FBI will involve religious counselling encouraging the caregivers/parents to stay in the hospital until their baby is medically discharged. This will also involve offering of prayers and reading of holy books for the babies’ recovery based on their faith. Each participant will have 2-3 sessions of the FBI with each session lasting 20-30 minutes.
Criteria for discontinuing or modifying allocated interventions {11b}
Participants who wish to exit study after due counselling will be allowed.
Strategies to improve adherence to interventions {11c}
Prior to recruitment, parents/caregivers of study participant will be educated on the study in order to gain their cooperation.
Relevant concomitant care permitted or prohibited during the trial {11d}
Both the experimental and control group will have access to medical treatment based on their conditions except for the intervention in the experimental arm.
Provisions for post-trial care {30}
The outcome measure is a one time off measure and would not require follow up.
Outcomes {12}
The primary outcome
- The primary outcome of this study is the retention rate of sick newborns with the faith-based intervention in public tertiary hospitals in Nigeria compared with the standard of care.
Secondary outcomes
- The secondary outcomes are reasons and determinants of DAMA among the neonates in the tertiary hospitals in Nigeria.
- Effect of parents/caregivers’ religiosity, spirituality, types of FBI, the sect of parents/caregivers and social support on the outcomes of DAMA or hospital retention in neonatal admission.
- Patients’ clinical outcome
- Parents/caregivers’ satisfaction with intervention and their desire to see the intervention established as routine care for newborn in public tertiary hospital.
Participant timeline {13}
Table 2 Participant timeline[1]
STUDY PERIOD
|
Enrolment
|
Allocation
|
Post-allocation
|
Close-out
|
TIMEPOINT**
|
-t1
|
0
|
12hs
|
72hrs
|
tx
|
ENROLMENT:
|
Eligibility screen
|
X
|
Informed consent
|
X
|
Administration of
Research
screening tools
|
X
|
Clinical History
and
examination
|
X
|
X
|
Allocation
|
X
|
INTERVENTIONS:
|
[Intervention A]
|
X
|
X
|
[Intervention B]
|
ASSESSMENTS:
|
[List outcome variables]
|
X
|
Sample size {14}
The sample size required for this study was determined using the Raosoft sample size calculator (http://www.raosoft.com/samplesize.html) for single proportion with estimated 50% prevalence of DAMA. A sample size of 359 has 80 % power to detect the rate of DAMA at the alpha level of significance 0.05.
Recruitment {15}
Invitation: The caregivers/parents of the eligible patients will be verbally invited during their hospital admission.
Eligibility: Subjects will be assessed based on the eligibility criteria enumerated above.
Enrolment: Eligible subjects will be enrolled into the study after giving written informed consent.
Informed Consent: Parents and caregivers will give a written informed consent during enrolment. This will be signed by Principal Investigator, the parent/caregiver, and a witness. A copy of informed consent will be retained by the parent, while a copy will be kept in the patient’s file.
Sampling technique
In stage I: The list of the tertiary hospitals in Nigeria formed the sample frame for the study. A random number was allocated to each centre. Two institutions were randomly selected from this list.
In Stage II, an allocation sequence for the 2 arms will be generated using simple randomization from GraphPad Prism version 9. In the selected hospitals, consecutive neonates whose parents/caregivers give informed consented would be allocated to one of the 2 arms based on the allocation sequence.
Allocation:
Allocation will be by simple randomization using random numbers generated from GraphPad Prism (version 9) for the study.
- Arm A: The intervention for FBI
- Arm B: The standard of care for neonates admitted into the unit born units of selected hospital
Subjects will be allocated to two arms of the study in parallel (concurrent): faith-based intervention (Arm A) and standard of care (Arm B) based on the randomization process. The allocation ratio is 1:1.
Assignment of interventions: allocation
Sequence generation {16a}
A random number will be generated using simple randomization from GraphPad Prism version 9 for consecutive patient being enrolled for the study.
Concealment mechanism {16b}
This study will be open label (Masking Not Used)
Implementation {16c}
A record officer will be responsible for generating a random number and its allocation using GraphPad Prism version 9.
Assignment of interventions: Blinding
Who will be blinded {17a}
This is open label trial. The intervention and comparator will not be concealed. Both the investigator and the subject will be aware of what intervention they would receive.
Procedure for unblinding if needed {17b}
This study will be open label (Masking Not Used)
Data collection and management
Plans for assessment and collection of outcomes {18a}
Training will be held for the researchers prior to commencement of the trial via zoom meeting. The validated questionnaire, the trial protocol, religiosity, spirituality and social scales would be tested. The experience with understanding the tools and the ease of administration of the tools would be assessed. Observation from the training will be incorporated into the study instruments to improve the data entry and address other observed limitations.
Plans to promote participant retention and complete follow-up {18b}
The outcome of the study is one time point: until DAMA occurs or medical discharge, follow-up does not apply.
Data management {19}
Data obtained from the study will be entered into a password protected and encrypted institutional REDCap database. Only specific individuals from the collaborating centres will be given access to the database. All data from all the centres will be de-identified and managed through secure code.
Confidentiality {27}
All information collected in this study will be given code numbers, and no name will be recorded. This cannot be linked to the patients, parents or care provider in any way. Identifier will not be used in any publication or reports from the study.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
This trial has no intention to collect biologic sample for genetic study.
Statistical methods for primary and secondary outcomes {20a}
Data from this study will be analysed in GraphPad Prism 9 (GraphPad Software 2365 Northside Dr. Suite 560 San Diego, CA 92108). The appropriate descriptive statistics will be used to present the socio demographic characteristics of study participants. The comparison of ccategorical outcomes between the arms will be analysed using the Chi-squared or Fisher’s exact tests, as appropriate, and presented as risk differences, risk ratios, or odds ratios and 95% confidence intervals. P-values < 0.05 will be considered statistically significant for all analyses.
Interim analyses {21b}
Data will be analysed at the end of the study
Methods for additional analyses (e.g., subgroup analyses) {20b}
Subgroup analysis will be performed using variables such as geopolitical region, gender, socioeconomic status of parents and care provider, level of education and occupation.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
The result of the study will be analysed per protocol. Missing data will be accounted for and the proportion with desirable outcome will be analyzed.
Plans to give access to the full protocol, participant level-data and statistical code {31c}
The protocol shall be published in a peered review journal and made publicly accessible to interested individuals or body.
Individual Patient data will be de-identified and stored encrypted in a password protected computer. De-identified data will also be stored in highly secured cloud computing. The participant level dataset and statistical code shall be made available after following due process adhering to good ethical standard.
Sharing Time Frame
The de-identified data will be publicly available for 2 years on the trial website.
Key Access Criteria
Open access to de-identified data set which can be used for any analysis related to discharged against medical advice (DAMA)
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
A trial steering committee will consist of the principal investigator, two scientific enquirers, the public enquirer and a biostatistician. They will meet frequently to provide an oversight function for the trial conduct over the two centres in the country.
Each centre will have a hospital trial group headed by a consultant paediatrician who will be responsible for running daily events in the hospital, providing organizational support and reporting on a weekly basis to the steering committee.
Composition of the data monitoring committee, its role and reporting structure {21a}
The Data monitoring committee will consist of the Head of the Information Technology at the University College Hospital Ibadan. He will centrally manage the database. He will be support by two assistants in event he is unable to perform his duties. They will be responsible for entering data from the UCH centre to the database. The Head will give access to focal persons (information technologist) at the collaborating centres in Nigeria. These individuals will be responsible for entering data into the central database in UCH. Regular Zoom meeting will be head among the group members to address pressing issues. The data monitoring committee shall be independent of the core trial committee.
Adverse event reporting and harms {22}
The trial is a social intervention. If any incident of abuse is reported by any participant, it will be handled on case-by-case bases by the steering committee.
Frequency and plans for auditing trial conduct {23}
The local ethics board will monitor the progress of this trial and the intervention, and update will be relayed to the body as events unfold.
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
Any modification to the protocol or trial update will be communicated to the Ethical Approval bodies, Trial Registry and any other relevant parties.
Dissemination plans {31a}
The outcome of this study will be communicated to participants, ethics board, healthcare professionals. It will be published in peer-reviewed scientific journals for public access. Data will be made available to the public maintaining ethic guidance.