Observational Study Exploring the Timing of Postnatal Neonate Weight Measurements
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neonates From Birth up to 5 Days Postpartum. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will help us address the national question of when is the best day to weigh neonates to ensure we give neonates the best possible chance within the first week of their life, maximizing breastmilk without giving formula unnecessarily for weight loss management, and improved maternal mental health.
Detailed description
The impact of even 1 formula supplementation can have detrimental effects on both mum and baby; decreased eagerness to breastfeed - leading to low milk supply, can trigger allergic sensitisation, and loss of confidence for the mother in breastfeeding. Maternal mental health within the first week of the postnatal period can be a turbulent time with increased hormones levels and adapting to a new normal. Ensuring good well-being of mothers is incredibly important to ensure the mother is able to bond well with her baby - a healthy loving relationship between parents and babies is integral to the brain development of the baby. Exposure in the first 1 year of the baby's life is the most integral part in helping to shape their emotional, cognitive and social capabilities (HM Government, 2021). This research project is of local and national importance for patient and parent care to improve long term health benefits of protecting breastfeeding journeys.
The main aim of the study is to collect data on the weight of neonates in the first 5 days of life.
Women will be consented in the first 24 hours following the birth of their baby if they fit the criteria. Baseline information will be collected:
* Time \& Date of birth * Type of birth * Weight at birth * Any medical risk factors i.e diabetes, high blood pressure etc * Feeding type (breastfeeding, formula, or both) * Gestation at birth
A maternity support worker will be tasked with weighing all the babies as near to their birth times possible and all data will be collected and logged. Following this the data will be sorted and correlated to look for any trends:
* What day had the biggest weight loss * When did the weight begin to increase * Were bigger weight losses linked with a certain type of birth or medical condition that the patient had * Did the gestational age when the baby was born have any link with greater weight loss
The end of the study will be defined as the date when the last baby entered into the study had had their final weight completed at the end of the 5-day period. This also included the collection of all weight data for the 5-day duration and any necessary data validation and quality checks. Following the final weight measurement, the data will be prepared for analysis to examine the trends in weight loss/gain over the study period. The results will be analysed and disseminated as outlined. Following on from this pilot study, it is hoped that a larger national study will take place to continue to collect weight loss data and help define the normal weight loss/gain which neonates experience in the first few days of life.
Primary outcome measures
- To find out when the best day to weigh a newborn baby is between birth and 5 days. [Time frame: Between birth and 5 days old of newborn baby.]
Eligibility criteria
Inclusion criteria
\- Any patient who births their baby within the timeframe of the data collection will be eligible to join the study
Exclusion criteria
- Patients who birth their babies outside of the range as above.
- Babies who are admitted to the neonatal unit from birth.
- Mothers less than 16 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- East Suffolk and North Essex NHS Foundation Trust — Ipswich
Identifiers
NCT: NCT07599332 · 22/100