Patient EmpowermentACUNENCT05005988
Actions for Empowered Maternal Neonatal Care (ACUNE): A Nursing Intervention
A study testing Actions for Empowered Maternal Neonatal Care in people with Patient Empowerment, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Patient Empowerment
- What is being tested?
- Actions for Empowered Maternal Neonatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 20 Oct 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mothers of premature infants less than 37 weeks gestational age at birth.
- Mothers of premature infants hospitalized in the neonatal intensive care unit
Who cannot join
- Mothers with previous experience in caring for a premature infant.
- Mothers whose children have some type of congenital malformation.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Sandra Osorio
Medellín, Antioquia, 050001
Sandra P Osorio Galeano, Master, (57)3004559227, sandra.osorio@udea.edu.co
Angela M Salazar Maya, PhD, (57)3113214501, angela.salazar@udea.edu.co
About this study
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
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.
- Conditions
- Patient Empowerment
- Being tested
- Actions for Empowered Maternal Neonatal Care
- Keywords
- Health education, Discharge patient, Neonatal Nursing, Neonatal Intensive Care Unit
- Medical subject headings
- Patient Participation, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actions for Empowered Maternal Neonatal CareBehavioural
Also called ACUNE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Weight of the premature infant in grams. Measurements obtained by the percentile curve are evaluated.
Measured: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.
Readmission
Readmission iin the week following hospital discharge
Measured: One week after the discharge
Emergency visits
Emergency visits number in the firts week after discharge
Measured: One week after discharge
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.
Measured: One week after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start20 Oct 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SANDRA PATRICIA OSORIO GALEANO, Universidad de Antioquia
- Investigators
- Sandra P Osorio Galeano, MD, Principal investigator, Universidad de AntioquiaAngela M Salazar Maya, PhD, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005988
- Sponsor's protocol ID
- CEI-FE2020-02
- Acronym
- ACUNE
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34214287Osorio-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.
PubMed 41637376
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05005988
- Acronym / sponsor ID
- ACUNE / CEI-FE2020-02
- Conditions
- Patient Empowerment
- Keywords
- Health education, Discharge patient, Neonatal Nursing, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Empowerment educational intervention | Experimental | Behavioral: Actions for Empowered Maternal Neonatal CareThree 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. |
| Usual intervention | No intervention | –Mothers receive information for home infant care, no theoretical perspective and no empowerment approach is considered |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Mothers of premature infants less than 37 weeks gestational age at birth.
- Mothers of premature infants hospitalized in the neonatal intensive care unit
Key exclusion criteria (2 listed)
- Mothers with previous experience in caring for a premature infant.
- Mothers whose children have some type of congenital malformation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actions for Empowered Maternal Neonatal CareAlso: ACUNEThe 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. | Behavioural | Empowerment educational intervention |
Primary outcome
Change in the caregiver's competence
Time frame: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.
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
4 secondary outcomes
Change in premature infant body weight
Time frame: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.
Readmission
Time frame: One week after the discharge
Emergency visits
Time frame: One week after discharge
Exclusive breastfeeding
Time frame: One week after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 34214287Osorio 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.
- Derived from this study: PubMed 41637376Osorio-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra P Osorio Galeano, MD principal investigator
Universidad de Antioquia
Angela M Salazar Maya, PhD study director
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actions for Empowered Maternal Neonatal Care in people with Patient Empowerment, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra P Osorio Galeano, MD ((57)3004559227, sandra.osorio@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the caregiver's competence (time frame: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.