The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants

Wuhan University

Status: Unknown

Conditions: Preterm Infant

Treatments: Behavioral: Nurse-led Continuous Support; Procedure: routine follow-up care

Study type: Interventional

Funder types: Other

Identifiers

NCT03151122

2017-04

Details and patient eligibility

About

The objective of the study is to establish a continuous nurse-led integrated support program and to exam its impact on preterm infant neurodevelopment.

Research hypotheses include:1. The continuous nurse-led integrated support will have significant impact on preterm infant neurodevelopment; 2.The support program will also have positive effect on parent psychological well-being.

Full description

The objective of the study is to establish the continuous nurse-led integrated support program as well as exam its impact on neurodevelopmental health of preterm infants.

Research hypotheses:

1. Compared to control group, the preterm infants in the interventional group will experience significantly better performance on neuromotor, cognitive and social-emotional function at corrected age of 3 month;
2. In comparison with those receiving routine support, parents receiving nurse-led continuous support will have significantly higher parental self-efficacy and exhibited better psychological well-being;
3. Maternal parenting self-efficacy will mediate the relationship between nurse-led support and preterm infant neurodevelopment.

Enrollment: 140 estimated patients

Sex: All

Ages: 28 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants born between 28-36 weeks of gestation;
• Parents residing in the same region for at least 5 years; .Parents agree to participate in the study.

Exclusion criteria

• infants with severe perinatal brain injury;
• infant with congenital anomalies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

continuous care group

Experimental group

Description:

continuous care group (CCG): This is the experimental group where continuous care supported would be offered by the nurse coordinated integrative health care team. which is, parents in this group receive support during infant hospitalization. The support covers both hospitalization phase and after-discharge phase. In-hospital support include educational support and promoting mother-infant attachment. Nurses will be responsible for home visits after infant discharge.

Treatment:

Behavioral: Nurse-led Continuous Support

routine care group

Active Comparator group

Description:

Routine Care Group (RCG): This is the comparison group of preterm infants. the routine care interventions generally include telephone reminding about follow-up care of the infants and hotline for parents to call when needed.

Treatment:

Procedure: routine follow-up care