Clinical trial NCT05005988: Actions for Empowered Maternal Neonatal Care (ACUNE): A Nursing Intervention
Official title: Actions for Empowered Maternal Neonatal Care (ACUNE): Nursing Intervention to Strengthen Mothers' Competence to Care for Their Preterm Infants at Home. A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Empowerment
Keywords: Health education
Discharge patient
Neonatal Nursing
Neonatal Intensive Care Unit
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded, parallel, randomized clinical trial. Mothers in the intervention group will receive a pre-discharge empowerment educational intervention, and the control group will receive the usual discharge preparation. Three 30-minute sessions will be conducted with each mother in the intervention group, the first during the first week after admission, the second session within 7 days after the second session, and the third 3 to 2 days before discharge. An induction to the out-of-hospital kangaroo program will also take place on the day of admission to the program. Mothers will receive a booklet with general care contents and empowerment information. Mothers in the control group will receive the usual preparation for discharge from the NICU. Response variables will be measured at three time points: At admission (baseline), before discharge and one week after the discharge.
Primary purpose: PREVENTION

Brief summary: The quality of care premature infants receive at home after hospital discharge is critical to their health and well-being. Premature infants require special care, which is why Neonatal Intensive Care Units (NICUs) have processes in place to prepare mothers for discharge. However, this experience is very complex for mothers, who often experience high levels of stress, anxiety, sadness and uncertainty. Mothers need knowledge and skills about caring for a premature infant, but they also need to gain confidence, believe in their abilities, and become empowered to participate more actively and confidently in decisions that have to do with their child's health. Several approaches exist to prepare mothers for home-based infant care; in the present study, an intervention focused on empowerment is proposed as a way to strengthen mothers' competence to care for their preterm infants and improve infant health outcomes. The intervention is expected to have adequate acceptability and feasibility, as well as preliminary evidence that it improves mothers' competence to care for their infants and decreases readmissions, emergency department visits, improves weight gain and health outcomes of preterm infants.

Detailed description: Premature children have a higher risk of becoming ill and dying than full-term children and that risk do not end with hospitalization, so the care they receive at home is decisive in their health and wellbeing. Preterm infants are especially vulnerable and have a greater number of readmissions and emergency visits after discharge, as well as delays in vaccination, infections as well as nutritional alterations.

Women play central in family health, and it is necessary to design and applying interventions to facilitate a woman's empowerment, specially to care premature son at home after Neonatal Intensive Care Units (NICU) discharge. Preparation for discharge has been described in the literature as a process where the mothers develop skills and knowledge that they will need to care for their premature children once they are at home. However, for mothers, they face a challenging task in which they experience high levels of stress, fear and uncertainty. Premature children require particular care and the mothers need more than knowledge and skills, they also need to get confidence, believe in their abilities and empowerment themselves to participate more actively and safely in decisions that have to do with the health of their children. This study arises from the need to prepare mothers through the possibilities of empowerment, as a way to improve the health outcomes of premature children. A Randomized Clinical Trial is proposed to establish the effect of the educational intervention of empowerment on mothers' competence in premature infant care, readmissions, weight gain, exclusive breastfeeding and other aspects related to the health, survival and well-being of premature infants. The intervention was designed by integrating the theoretical approach, empirical evidence and the results of a qualitative study in which mothers and fathers of premature infants participated, which gives a participatory approach to the research and makes it close to the parents' reality and gives it social relevance.

Eligibility criteria: Inclusion Criteria:

* Mothers of premature infants less than 37 weeks gestational age at birth.
* Mothers of premature infants hospitalized in the neonatal intensive care unit

Exclusion Criteria:

* Mothers with previous experience in caring for a premature infant.
* Mothers whose children have some type of congenital malformation.

Primary outcomes:
measure: Change in the caregiver's competence
timeFrame: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.
Secondary outcomes:
measure: Change in premature infant body weight
timeFrame: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.
measure: Readmission
timeFrame: One week after the discharge
measure: Emergency visits
timeFrame: One week after discharge
measure: Exclusive breastfeeding
timeFrame: One week after discharge
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Sandra Osorio
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Sandra P Osorio Galeano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia
name: Angela M Salazar Maya, PhD
role: STUDY_DIRECTOR
References:
citation: Osorio Galeano SP, Salazar Maya AM. Experiences of Parents of Preterm Children Hospitalized Regarding Restrictions to Interact with Their Children Imposed Because of the COVID-19 Pandemic. Invest Educ Enferm. 2021 Jun;39(2):e10. doi: 10.17533/udea.iee.v39n2e10.