CClinicalTrials.gg
Status unknownNCT05005988ACUNEUpdated Feb 3, 2022

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

An interventional study of Actions for Empowered Maternal Neonatal Care in Patient Empowerment, sponsored by Universidad de Antioquia. Status unknown at 1 site in Colombia. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
15 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Patient Empowerment

Keywords

  • Health education
  • Discharge patient
  • Neonatal Nursing
  • Neonatal Intensive Care Unit
03

In context

Lead sponsor

Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Mothers with previous experience in caring for a premature infant.
  • Mothers whose children have some type of congenital malformation.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Actions for Empowered Maternal Neonatal Care

  • No intervention
    Usual intervention

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

Interventions

  • BehavioralActions 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.

    Also known as: ACUNE

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What researchers measure

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

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

Secondary outcomes

  1. Change in premature infant body weight

    Weight of the premature infant in grams. Measurements obtained by the percentile curve are evaluated.

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

  2. Readmission

    Readmission iin the week following hospital discharge

    Time frame: One week after the discharge

  3. Emergency visits

    Emergency visits number in the firts week after discharge

    Time frame: One week after discharge

  4. Exclusive breastfeeding

    Exclusive breastfeeding refers to whether the mother covers all of her child's feeding needs with breast milk. To establish this, a questionnaire will be used to determine how many times a day she expresses breast milk and how many cubic centimeters of breast milk she expresses, whether the premature child has a good suckling ability and whether she has had to give her child formula milk to supplement his or her diet.

    Time frame: One week after discharge

07

Study locations

1 of 1 sites recruiting
  • Sandra Osorio
    Medellín, Antioquia 050001, Colombia
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34214287 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05005988
Lead sponsor
Universidad de Antioquia
Responsible party
SANDRA PATRICIA OSORIO GALEANO (Principal Investigator, Universidad de Antioquia) — Principal investigator
First posted
Aug 16, 2021
Start date
Oct 20, 2021
Primary completion
Mar 30, 2022 (estimated)
Completion
May 30, 2022 (estimated)
Last update
Feb 3, 2022

Study contacts

Sandra P Osorio Galeano, MD
Contact
sandra.osorio@udea.edu.co
(57)3004559227
Angela M Salazar Maya, PhD
Contact
angela.salazar@udea.edu.co
(57)3113214501
Sandra P Osorio Galeano, MD
principal investigator · Universidad de Antioquia
Angela M Salazar Maya, PhD
study director · Universidad de Antioquia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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