The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Aug 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how Family Integrated Care (FICare) can affect melatonin levels and other health outcomes in very low birth weight infants (those who weigh less than 3.3 pounds at birth). FICare means that families will be actively involved in their baby's care while they are in the neonatal intensive care unit (NICU). This study aims to see if having parents participate in daily care helps both the babies and the parents.

To be eligible for this study, babies must weigh less than 1,500 grams (about 3.3 pounds) and be born before 32 weeks of pregnancy. Parents need to be able to cooperate and willing to take part in training to care for their baby for at least 6 hours a day over a span of 21 days. It's important to note that babies who need special treatments or have certain health problems will not be included in the trial. If you choose to participate, you can expect to learn how to care for your baby while also contributing to important research that could improve care for future infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Birth weight \< 1500g;
• • Gestational age \< 32w;
• • Admit within 24 hours of birth;
• • The parents are conscious and able to cooperate, have certain learning and reading comprehension skills, and are capable of caring for their babies. They are committed to receiving training and caring for their babies for not less than 6 hours a day for at least 21 days;
• • Voluntarily participate in this study and sign informed consent.
• • Exclusion Criteria
• • Newborns who require palliative care or surgical intervention;
• • OI (oxygenation index) \<300 ;
• • Newborns with severe congenital malformations;