The Effect of Family Integrated Care on Preparing Parents With Premature Infants Hospitalized in the Neonatal Intensive Care Unit for Discharge

NCT04478162 | Completed

• 1 other identifier: 16214662/050.01.04/14
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Physiological and structural features of premature infants differ from mature newborns. Families worry about touching their very sensitive and fragile babies, which are quite different from their expectations, and they seriously concern about how they will take care of their babies who are cared for by the specialist staff at the hospital when they are discharged to home. Different approaches and models are applied in the Neonatal Intensive Care Units (NICU) to prepare families, especially mothers, for the discharge process and to overcome these fears of the parents. However, most of the time, investigators observe in both researches and units that these approaches are not efficient. In this study, which investigators started with the questions as "What can investigators do better in this issue?" and "How can investigators help families more in this process?", investigator have seen that Family Integrated Care (FICare) model is applied in some clinics abroad and successful results have been obtained. However, investigators did not come across a study that applied this model and examined the effect of it on parents on being ready for discharge. Since this study will be a first in terms of both this aspect and the application of this model in our country, in this unique study, investigators aim to draw attention to this approach in our country, also contribute to keeping the premature babies healthy. Research Hypotheses: H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group. H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group. H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group.

Conditions

Neonatal Intensive Care Unit; Parents

Keywords

premature; Family Integrated Care; discharge; readiness; parents

Outcome Measures

Primary Outcomes (1)

• Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.

  With the questionnaire to be used separately for mothers (Preparedness for Discharge Scale of the Mother with a Premature Baby in the Neonatal Intensive Care Unit) and fathers (Preparedness for Discharge Scale of the Father with a Premature Baby in the Neonatal Intensive Care Unit) with premature babies, their readiness for discharge will be measured. A minimum score of 22, a maximum of 154 points are obtained from the form applied to mothers, a minimum of 20 and a maximum of 140 points from the form applied to fathers. High scores indicate that parents are ready for discharge.

  up to nine months

Secondary Outcomes (1)

• Premature infants weight (kg)

  up to nine months

Study Arms (2)

Experimental

EXPERIMENTAL

All phases of the FICare model have been implemented. Parents in the intervention group were included in a one-week training program within the scope of the Family Integrated Care model. A maximum of four couples attended the training in each session. A training program was also organized at weekend for those who could not attend it during the week. Training subjects consisted of the importance of breast milk, breastfeeding positions, hygienic care practices (eyes, nose, mouth, ears, skin, diaper change), bathing, nail clipping, kangaroo care, drug administration, first and emergency support, safe sleep, doctor check-up times, and vaccine follow-ups. Care practices were first shown on the model infant, and parents were asked to practice on the model. When the clinical stabilization of their infants was achieved, parents were asked to attend at least three caregiving sessions and stay in the hospital for an average of six to eight hours.

Other: Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.

Control Groups

NO INTERVENTION

Individuals received usual care provided by nurses from the time the premature infant was admitted to the NICU until discharge. The usual care process is carried on between the nurse and the mother. Mothers are allowed to perform limited care practices (bottom cleaning, breastfeeding) that the nurse considers appropriate. Mothers of babies who are planned to be discharged start staying in the hospital approximately 2 days before. Fathers are not included in the care and process. They are not allowed to stay in the hospital. Fathers are only informed and not included in the care.

Interventions

Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model. OTHER

At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement,

Experimental

Eligibility Criteria

• Age: 19 Years - 50 Years
• Gender Eligibility Details: Parents with premature babies at NICU
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Birth of the infant at the 28th-34th weeks of gestation,
• First parenting experience of the mother and the father,
• Parents' willingness to participate in the study and being open to communication,
• Mother having breast milk,
• Participation of parents in the discharge training program.

You may not qualify if:

• Undergoing a surgical intervention,
• Death of the baby
• Transfer of the baby to another hospital,
• Failure of the parent to complete all phases of the study.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya Education and Training Hospital

Sakarya, Adapazarı, 54050, Turkey (Türkiye)

Location

Related Publications (1)

• Tiryaki O, Cinar N, Caner I. The effect of family integrated care on preparing parents with premature infants hospitalized in the neonatal intensive care unit for discharge. J Perinatol. 2024 Jul;44(7):1014-1021. doi: 10.1038/s41372-024-01931-5. Epub 2024 Mar 18.

  PMID: 38499753 DERIVED

Related Links

• httpp
• Related Info

MeSH Terms

Conditions

Premature Birth

Interventions

Drainage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Nursan ÇINAR, Proffesor

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomization will be done through the program with the Uniform Resource Locator (URL) address httpp://www.randomizer.org and it is planned to work with 1 month intervention and 1 month control group to prevent the groups from being affected by each other.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 20, 2020
• Study Start: February 6, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)