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

NCT05005988 | Unknown

• 1 other identifier: CEI-FE2020-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Empowerment

Keywords

Health education; Discharge patient; Neonatal Nursing; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Change in the caregiver's competence

  The caregiver's competence is the capacity, ability and preparation that the caregiver has to perform his or her caregiving task at home and can be measured with the CUIDAR scale, which was designed and validated in Colombia. This scale has been used in several studies, confirming its validity and reliability. To determine the validity and reliability of the CUIDAR instrument in mothers of premature infants, a cross-sectional quantitative study was carried out in which its psychometric properties were measured. 207 mothers of premature infants participated. A factor analysis did not confirm the original structure in the new population, but a model with 7 factors and 33 items with a Cronbach's alpha of 0.852 and adequate goodness-of-fit indices. The new version of the scale, named CUIDAR-PreMa, has 7 dimensions: Acting, Coping, Bonding, Social Support, General Knowledge, Singularity and Specific Knowledge. The scale has 33 items, with a Likert-type scale

  At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.

Secondary Outcomes (4)

• Change in premature infant body weight

  At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.

• Readmission

  One week after the discharge

• Emergency visits

  One week after discharge

• Exclusive breastfeeding

  One week after discharge

Study Arms (2)

Empowerment educational intervention

EXPERIMENTAL

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.

Behavioral: Actions for Empowered Maternal Neonatal Care

Usual intervention

NO INTERVENTION

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

Interventions

Actions for Empowered Maternal Neonatal Care 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.

Also known as: ACUNE

Empowerment educational intervention

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Sandra Osorio

Medellín, Antioquia, 050001, Colombia

RECRUITING

Related Publications (2)

• 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.

  PMID: 34214287 BACKGROUND

• Osorio-Galeano SP, Salazar-Maya AM. Design and assessment of an intervention for parents of premature newborns: a mixed-methods study. Rev Lat Am Enfermagem. 2026 Feb 2;34:e4747. doi: 10.1590/1518-8345.7791.4747. eCollection 2026.

  PMID: 41637376 DERIVED

MeSH Terms

Conditions

Patient Participation; Health Education

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance

Study Officials

• Sandra P Osorio Galeano, MD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

• Angela M Salazar Maya, PhD

  Universidad de Antioquia

  STUDY DIRECTOR

Central Study Contacts

Sandra P Osorio Galeano, MD

CONTACT

(57)3004559227; sandra.osorio@udea.edu.co

Angela M Salazar Maya, PhD

CONTACT

(57)3113214501; angela.salazar@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator will be external to the intervention and will not know whether the mothers belong to the intervention or control group. This person will be trained and standardized in the handling of the instruments, will know the general elements of the study, and will ensure compliance with the ethical conditions established in the study. Outcome evaluator will be informed at the time of applying the instruments and recording the information related to the variables of interest of the study and will verify the complete filling out of the instruments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 16, 2021
• Study Start: October 20, 2021
• Primary Completion: March 30, 2022
• Study Completion: May 30, 2022
• Last Updated: February 3, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)