Actions for Empowered Maternal Neonatal Care (ACUNE): A Nursing Intervention

NCT ID: NCT05005988

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-05-30

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.

Conditions

Patient Empowerment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Empowerment educational intervention

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.

Group Type: EXPERIMENTAL

Actions for Empowered Maternal Neonatal Care

Intervention Type: BEHAVIORAL

The intervention includes three 30-minute face-to-face sessions:

Session 1. Recognizing prematurity and the NICU environment: includes definitions of prematurity, characteristics of premature infants, equipment and dynamics of NICU care. Mothers are encouraged to identify their own and contextual resources that can help empower them.

Session 2. Identifying the care of a premature baby: aspects related to the kangaroo method, feeding, thermoregulation, among others, are presented. Knowledge is presented as an empowerment resource.

Session 3: Preparation for the return home. Aspects related to the discharge process and transition to home are described. Includes information on the transition home, warning signs, emergency situations, physical burden, and recognition of sources of personal and professional support.

Session on admission to the out-of-hospital kangaroo program: presents the dynamics of the kangaroo program, as well as the goals in the new care setting.

Usual intervention

Mothers receive information for home infant care, no theoretical perspective and no empowerment approach is considered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Actions for Empowered Maternal Neonatal Care

The intervention includes three 30-minute face-to-face sessions:

Session 1. Recognizing prematurity and the NICU environment: includes definitions of prematurity, characteristics of premature infants, equipment and dynamics of NICU care. Mothers are encouraged to identify their own and contextual resources that can help empower them.

Session 2. Identifying the care of a premature baby: aspects related to the kangaroo method, feeding, thermoregulation, among others, are presented. Knowledge is presented as an empowerment resource.

Session 3: Preparation for the return home. Aspects related to the discharge process and transition to home are described. Includes information on the transition home, warning signs, emergency situations, physical burden, and recognition of sources of personal and professional support.

Session on admission to the out-of-hospital kangaroo program: presents the dynamics of the kangaroo program, as well as the goals in the new care setting.

Intervention Type: BEHAVIORAL

Other Intervention Names

ACUNE

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

SANDRA PATRICIA OSORIO GALEANO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra P Osorio Galeano, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Angela M Salazar Maya, PhD

Role: STUDY_DIRECTOR

Universidad de Antioquia

Locations

Sandra Osorio

Medellín, Antioquia, Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Sandra P Osorio Galeano, MD

Role: CONTACT

sandra.osorio@udea.edu.co

(57)3004559227

Angela M Salazar Maya, PhD

Role: CONTACT

angela.salazar@udea.edu.co

(57)3113214501

Facility Contacts

Sandra P Osorio Galeano, Master

Role: primary

sandra.osorio@udea.edu.co

(57)3004559227

Angela M Salazar Maya, PhD

Role: backup

angela.salazar@udea.edu.co

(57)3113214501

References

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.

Reference Type: BACKGROUND

PMID: 34214287 (View on PubMed)

Other Identifiers

CEI-FE2020-02

Identifier Type: -

Identifier Source: org_study_id