Skip to content

Mechanical study of Family-Integrated-Care (FICare) to improve the outcomes of preterm infants in Neonatal Intensive Care Unit.

Mechanical study of Family-Integrated-Care (FICare) to improve the outcomes of preterm infants in Neonatal Intensive Care Unit.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-17011801
Enrollment
Unknown
Registered
2017-06-29
Start date
2019-05-31
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm

Interventions

FICare preterm group:Family Intergrated Care for hospitalized preterm infants
non-FICare preterm group:Care for the hospitalized preterm infatnts is completed by medical professionals
Normal term control group:no medical intervension

Sponsors

Beijing Children's Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.1 Years

Inclusion criteria

Inclusion criteria: 1. The general inclusion criteria of FICare patients are: (1) Gestational age less than 34 weeks; and (2) The enteral feeds have been started and consecutively increased for more than 24 hours; and (3) Vital signs of the infants have been stable for more than 48 hours; and (4) Parents agree to sign on the written consent; 2. The additional inclusion criteria for FICare infants in aEEG study are: (1) The patients need to be enrolled in FICare for more than 2 weeks; and (2) The patients will not be discharged within 3 days; and (3) Not receiving any sedation for more than 2 weeks; and (4) No episode of hypoglycaemia or convulsion after birth. 3. The additional inclusion criteria for FICare infants in intestinal flora study are: (1) Infants need to be enrolled in FICare for more than 4 weeks; and (2) The current amount of breastmilk feeding is more than 80ml/kg/day; and (3) The infants have never been fed any probiotics; and (4) The infants have not had any antibiotics for more than 2 weeks; and (5) At corrected gestational age of more than 42 weeks. 4. Inclusion criteria for infants in non-FICare group are: (1) Infants who are eligible to be enrolled in FICare but who are not actually enrolled in FICare; and (2) The current amount of breastmilk feeding is more than 80ml/kg/day; and (3) The infants have never been fed any probiotics; and (4) The infants have not had any antibiotics for more than 2 weeks; and (5) At corrected gestational age of more than 42 weeks; and (6) Parents agree to sign on the written consent. 5. Inclusion criteria for infants in normal term control group are: (1) Normally vaginal delivered term infants; and (2) Infants are fed with pure breast milk; and (3) Infants who have never been fed any probiotics; and (3) At postnatal 30 days of age, and (4) Has never behaved as being ill.

Exclusion criteria

Exclusion criteria: 1. Invasive ventilation support is required; or 2. Peri-operational infants; or 3. Palliative cared infants; or 4. Infants parents have social issues or t language barrier; or 5. Infant is likely to be discharged within 2weeks; or 6. Infants mother is not willing to commit to staying in the NICU for more than 3 hours/day.

Design outcomes

Primary

MeasureTime frame
aEEG;16S RNA determination of intestinal flora;

Secondary

MeasureTime frame
Demographic data;

Countries

China

Contacts

Public ContactMingyan Hei

Beijing Children's Hospital of Capital Medical University, The Third Xiangya Hospital of Central South University

heiming_yan@aliyun.com+86 13707313550

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026