A prospective, randomised pilot study in the management of neonates at risk of hypoglycaemia (34 weeks to term) by oral feeding using preterm formula.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13668937

Enrollment

Registered

2005-09-30

Start date

2004-04-05

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Neonatal Diseases Neonatal Diseases

Interventions

Randomisation of at least 10 in each arm, routine management of cannulation and intravenous glucose or oral feeding of Preterm formula.

Eligibility

Inclusion criteria

Inclusion criteria: Not provided at time of registration

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
The two groups are compared using independent t-tests. So calculating means or proportions per group with 95% Cls for the difference between means or proportions as appropriate. If there is an element of repeated measures (i.e. if measuring each person more than once) then calculate the area under the curve (AUC) for each group and then compare the AUCs for binary categorical data odds ratios again with 95% CIs, can be used. Somewhere, an arbitrary level of 5% significance (two-tailed) will be assumed. Randomisation will be according to a random numbers table. Even split can not be done with a small sample. Due to small sample, the method of minimisation may be used, when randomising, or randomise using blocks.	—

Measure

Time frame

The two groups are compared using independent t-tests. So calculating means or proportions per group with 95% Cls for the difference between means or proportions as appropriate. If there is an element of repeated measures (i.e. if measuring each person more than once) then calculate the area under the curve (AUC) for each group and then compare the AUCs for binary categorical data odds ratios again with 95% CIs, can be used. Somewhere, an arbitrary level of 5% significance (two-tailed) will be assumed. Randomisation will be according to a random numbers table. Even split can not be done with a small sample. Due to small sample, the method of minimisation may be used, when randomising, or randomise using blocks.

—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026