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

Patient Empowerment Clinical Trial

— ACUNE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005988
• Other study ID #: CEI-FE2020-02
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2021
• Source: Universidad de Antioquia
• Contact: Sandra P Osorio Galeano, MD
• Phone: (57)3004559227
• Email: sandra.osorio[@]udea.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patient Empowerment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Colombia	Sandra Osorio	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (1)

Osorio Galeano SP, Salazar Maya ÁM. 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). doi: 10.17533/udea.iee.v39n2e10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in premature infant body weight	Weight of the premature infant in grams. Measurements obtained by the percentile curve are evaluated.	At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.
Secondary	Readmission	Readmission iin the week following hospital discharge	One week after the discharge
Secondary	Emergency visits	Emergency visits number in the firts week after discharge	One week after discharge
Secondary	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.	One week after discharge